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Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version
2768815478,02/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/7/2022 in a 91 year old Female. On 2/7/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,67,02/07/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2768815986,02/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/14/2022 in a 84 year old Female. On 2/14/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,40,02/14/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2768810718,04/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/19/2022 in a 77 year old Female. On 4/20/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,68,04/19/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2572775356,11/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/3/2022 in a 65 year old Female. On 11/3/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,65,Female,47,11/03/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2572776230,11/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/10/2022 in a 70 year old Female. On 11/14/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,75,11/10/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2768815987,02/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/14/2022 in a 84 year old Female. On 2/14/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,40,02/14/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572775357,11/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/3/2022 in a 65 year old Female. On 11/4/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,65,Female,47,11/03/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572776231,11/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/10/2022 in a 70 year old Female. On 11/14/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,75,11/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572776232,11/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/10/2022 in a 70 year old Female. On 11/15/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,75,11/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572777109,11/17/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/17/2022 in a 82 year old Female. On 11/17/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,76,11/17/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572779365,12/16/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/14/2022 in a 83 year old Female. On 12/16/2022, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,73,12/14/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2704110309,01/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/19/2023 in a 80 year old Male. On 1/19/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,69,01/19/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2240773131,01/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/7/2022 in a 90 year old Female. On 1/19/2023, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Female,62,06/07/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2572777081,11/17/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/17/2022 in a 82 year old Female. On 11/17/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,76,11/17/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2168461636,01/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/14/2022 in a 83 year old Female. On 1/20/2023, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,73,12/14/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2768812196,06/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/13/2022 in a 83 year old Female. On 6/15/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,80,06/13/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2240768083,09/16/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/13/2022 in a 83 year old Female. On 9/16/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,80,06/13/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2572779372,12/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/14/2022 in a 83 year old Female. On 12/14/2022, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,73,12/14/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2766668682,08/26/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/23/2022 in a 81 year old Male. On 8/26/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,61,08/23/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2766668730,08/26/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 81 year old Female. On 8/26/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,75,08/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2766663985,11/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/1/2022 in a 84 year old Male. On 11/2/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Male,71,11/01/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572775253,11/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/3/2022 in a 82 year old Female. On 11/4/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,99,11/03/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572775445,11/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/3/2022 in a 80 year old Female. On 11/4/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,75,11/03/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572778696,12/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/6/2022 in a 75 year old Female. On 12/7/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Female,64,12/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572779381,12/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/14/2022 in a 83 year old Female. On 12/15/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,73,12/14/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572780107,12/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/20/2022 in a 93 year old Female. On 12/23/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,69,12/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2572777107,11/17/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/17/2022 in a 82 year old Female. On 11/17/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,76,11/17/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2704110312,01/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/19/2023 in a 80 year old Male. On 1/19/2023, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,69,01/19/2023,NI,2513,4648,2993,4755,4114;4119,3221,4315,NI,0
2704110313,01/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/19/2023 in a 80 year old Male. On 1/19/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,69,01/19/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2560040582,11/16/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/16/2021 in a 72 year old Male. On 11/16/2021, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Male,64,11/16/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504756796,02/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/15/2022 in a 59 year old Female. On 2/18/2022, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,59,Female,47,02/15/2022,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2504756813,02/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/15/2022 in a 59 year old Female. On 2/15/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,59,Female,47,02/15/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504756819,02/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/15/2022 in a 59 year old Female. On 2/18/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,59,Female,47,02/15/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2504756821,02/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/15/2022 in a 59 year old Female. On 2/18/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,59,Female,47,02/15/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504758997,03/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/24/2022 in a 85 year old Female. On 3/24/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,58,03/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504759004,03/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/24/2022 in a 85 year old Female. On 3/24/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,58,03/24/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2504759005,03/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/24/2022 in a 85 year old Female. On 3/24/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,58,03/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504742068,03/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/29/2022 in a 94 year old Female. On 3/29/2022, Percutaneous Coronary Intervention was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Percutaneous Coronary Intervention was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Female,42,03/29/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504747812,05/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 80 year old Female. On 5/28/2022, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,49,05/26/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2504747816,05/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 80 year old Female. On 5/28/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,49,05/26/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504747820,05/27/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 80 year old Female. On 5/27/2022, Device Migration was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Migration was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,49,05/26/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2504747829,05/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 80 year old Female. On 5/28/2022, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,49,05/26/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2557238253,08/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/2/2022 in a 91 year old Female. On 8/3/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,60,08/02/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2557225626,10/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/28/2022 in a 92 year old Female. On 10/3/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,47,09/28/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2557234753,11/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/1/2022 in a 78 year old Female. On 11/1/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,52,11/01/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2557234755,11/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/1/2022 in a 78 year old Female. On 11/1/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,52,11/01/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2760449680,01/21/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/20/2023 in a 66 year old Male. On 1/21/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,66,Male,78,01/20/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2664695466,01/13/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/13/2023 in a 84 year old Female. On 1/13/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,48,01/13/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2240549826,04/21/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/13/2023 in a 65 year old Male. On 4/21/2023, Stroke - Undetermined was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Undetermined was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,65,Male,114,04/13/2023,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2532851602,10/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/28/2022 in a 81 year old Male. On 10/28/2022, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,82,10/28/2022,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2126212692,12/19/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/17/2021 in a 84 year old Female. On 12/19/2021, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,67,12/17/2021,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2126212693,12/19/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/17/2021 in a 84 year old Female. On 12/19/2021, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,67,12/17/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2330761219,02/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/22/2022 in a 85 year old Female. On 2/23/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,76,02/22/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2377974364,05/26/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 86 year old Male. On 5/26/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,58,05/26/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2126211774,06/06/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 75 year old Male. On 6/6/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Male,133,05/26/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2126211786,05/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 75 year old Male. On 5/28/2022, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Male,133,05/26/2022,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2126211787,06/06/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/26/2022 in a 75 year old Male. On 6/6/2022, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Male,133,05/26/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2377975114,06/17/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/17/2022 in a 82 year old Female. On 6/17/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,57,06/17/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2377975128,06/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/17/2022 in a 82 year old Female. On 6/18/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,57,06/17/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2486065512,09/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/2/2022 in a 74 year old Female. On 9/3/2022, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Female,135,09/02/2022,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2177706361,09/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/2/2022 in a 74 year old Female. On 9/12/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Female,135,09/02/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2486064553,08/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/28/2022 in a 84 year old Male. On 8/29/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Male,72,07/28/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
1966868581,08/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/18/2022 in a 79 year old Female. On 8/22/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Female,99,08/18/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2486065435,09/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/2/2022 in a 85 year old Female. On 9/2/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,64,09/02/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2486065676,09/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/6/2022 in a 87 year old Male. On 9/8/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,96,09/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2177706607,09/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/22/2022 in a 69 year old Female. On 9/29/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Female,135,09/22/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2486066014,09/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/22/2022 in a 69 year old Female. On 9/22/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Female,135,09/22/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2486066015,09/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/22/2022 in a 69 year old Female. On 9/22/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Female,135,09/22/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2177707286,10/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/28/2022 in a 75 year old Female. On 10/28/2022, Stroke - Undetermined was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Undetermined was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Female,79,10/28/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2532852072,11/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/18/2022 in a 63 year old Female. On 11/18/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,63,Female,49,11/18/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2532852073,11/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/18/2022 in a 63 year old Female. On 11/18/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,63,Female,49,11/18/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2664695687,01/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/26/2023 in a 81 year old Male. On 1/26/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,102,01/26/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2532852601,12/09/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/9/2022 in a 86 year old Female. On 12/9/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Female,65,12/09/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2664695505,01/13/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/13/2023 in a 74 year old Male. On 1/13/2023, ICD was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of ICD was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,106,01/13/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2664695508,01/13/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/13/2023 in a 74 year old Male. On 1/13/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,106,01/13/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776412949,06/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/22/2023 in a 80 year old Female. On 6/22/2023, Annular Rupture was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Annular Rupture was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,92,06/22/2023,NI,3160,4624,2993,4755,4114;4119,3221,4315,NI,0
2776413179,06/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/22/2023 in a 81 year old Female. On 6/22/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,104,06/22/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2776413181,06/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/22/2023 in a 81 year old Female. On 6/22/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,104,06/22/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226753161,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/15/2021 in a 67 year old Female. On 3/30/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,67,Female,104,11/15/2021,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2226753176,06/16/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/15/2021 in a 68 year old Female. On 6/16/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,68,Female,104,11/15/2021,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2226753181,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/15/2021 in a 67 year old Female. On 3/30/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,67,Female,104,11/15/2021,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2226753182,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/15/2021 in a 67 year old Female. On 3/30/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,67,Female,104,11/15/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2567494332,11/15/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/15/2021 in a 77 year old Female. On 11/15/2021, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,117,11/15/2021,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2567496476,12/06/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/2/2021 in a 83 year old Female. On 12/6/2021, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,89,12/02/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2567496612,12/09/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/9/2021 in a 77 year old Male. On 12/9/2021, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Male,96,12/09/2021,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2567496626,12/16/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/9/2021 in a 77 year old Male. On 12/16/2021, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Male,96,12/09/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226753674,08/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/13/2021 in a 79 year old Female. On 8/1/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Female,101,12/13/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2567496924,12/14/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/13/2021 in a 84 year old Female. On 12/14/2021, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,44,12/13/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2567497068,12/21/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/20/2021 in a 73 year old Male. On 12/21/2021, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Male,98,12/20/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226765156,02/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/6/2022 in a 72 year old Female. On 2/8/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Female,64,01/06/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2226765173,02/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/6/2022 in a 72 year old Female. On 2/8/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Female,64,01/06/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772757928,01/13/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/13/2022 in a 75 year old Male. On 1/13/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Male,104,01/13/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772758405,01/31/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/27/2022 in a 80 year old Male. On 1/31/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,76,01/27/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226766482,02/10/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/7/2022 in a 87 year old Male. On 2/10/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,109,02/07/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772758843,02/10/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/10/2022 in a 78 year old Male. On 2/10/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Male,105,02/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772759756,02/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/24/2022 in a 77 year old Male. On 2/24/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Male,92,02/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226758181,05/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/10/2022 in a 78 year old Female. On 5/30/2022, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,56,03/10/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2226758182,05/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/10/2022 in a 78 year old Female. On 5/7/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,56,03/10/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2234226467,07/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/17/2022 in a 80 year old Male. On 7/8/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,66,03/17/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234226471,08/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/17/2022 in a 80 year old Male. On 8/5/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,66,03/17/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772761038,03/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/21/2022 in a 74 year old Male. On 3/21/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,118,03/21/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772761061,03/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/21/2022 in a 74 year old Male. On 3/21/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,118,03/21/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772761065,03/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/21/2022 in a 74 year old Male. On 3/21/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,118,03/21/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772761066,03/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/21/2022 in a 74 year old Male. On 3/21/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,118,03/21/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226759712,04/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/7/2022 in a 91 year old Female. On 4/8/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,53,04/07/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2234221267,01/03/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/11/2022 in a 82 year old Male. On 1/3/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Male,79,04/11/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2772755081,04/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/21/2022 in a 87 year old Male. On 4/21/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,85,04/21/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234221744,02/09/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/25/2022 in a 86 year old Male. On 2/9/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,91,04/25/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2234221757,10/06/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/25/2022 in a 85 year old Male. On 10/6/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,91,04/25/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772756196,05/19/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/19/2022 in a 92 year old Female. On 5/19/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,60,05/19/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234222075,12/17/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/23/2022 in a 97 year old Male. On 12/17/2022, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,97,Male,62,05/23/2022,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2772757009,06/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/6/2022 in a 81 year old Female. On 6/7/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,79,06/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772757248,06/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/16/2022 in a 71 year old Male. On 6/20/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Male,55,06/16/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234222507,04/28/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/16/2022 in a 72 year old Male. On 4/28/2023, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Male,55,06/16/2022,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2226754854,07/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 85 year old Male. On 7/1/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,115,06/20/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772757381,06/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 85 year old Male. On 6/20/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,115,06/20/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2772757395,06/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 85 year old Male. On 6/21/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,115,06/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772750335,07/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/7/2022 in a 82 year old Male. On 7/7/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Male,86,07/07/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226755257,09/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/18/2022 in a 76 year old Female. On 9/7/2022, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,66,07/18/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772750870,07/19/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/18/2022 in a 76 year old Female. On 7/19/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,66,07/18/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772752975,09/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/12/2022 in a 78 year old Male. On 9/12/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Male,116,09/12/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772753002,09/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/12/2022 in a 78 year old Male. On 9/12/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Male,116,09/12/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772753003,09/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/12/2022 in a 78 year old Male. On 9/12/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Male,116,09/12/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772753482,08/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/22/2022 in a 79 year old Female. On 8/22/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Female,63,08/22/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772745901,10/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/3/2022 in a 79 year old Male. On 10/4/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Male,99,10/03/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2226750663,11/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/29/2022 in a 72 year old Female. On 11/29/2022, Device Thrombosis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Thrombosis was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Female,70,09/29/2022,NI,4440,4648,4001,4755,4114;4119,3221,4315,NI,0
2226751147,11/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/17/2022 in a 84 year old Male. On 11/14/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Male,104,10/17/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2226752292,11/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/24/2022 in a 92 year old Female. On 11/24/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,51,10/24/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2234222863,11/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/14/2022 in a 90 year old Male. On 11/18/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Male,132,11/14/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772748099,11/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/10/2022 in a 80 year old Male. On 11/14/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,56,11/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772741888,01/18/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/9/2023 in a 95 year old Female. On 1/18/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,95,Female,86,01/09/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772744789,01/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/18/2023 in a 78 year old Female. On 1/20/2023, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,54,01/18/2023,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772744839,01/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/18/2023 in a 88 year old Male. On 1/19/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Male,67,01/18/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234225696,02/28/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2023 in a 77 year old Female. On 2/28/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,49,01/04/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2234225698,03/05/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2023 in a 77 year old Female. On 3/5/2023, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,49,01/04/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2234225707,02/28/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2023 in a 77 year old Female. On 2/28/2023, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,49,01/04/2023,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2234225708,03/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2023 in a 77 year old Female. On 3/1/2023, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of PCI was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,49,01/04/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234225718,03/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2023 in a 77 year old Female. On 3/1/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,49,01/04/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2046946643,11/10/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/6/2022 in a 84 year old Female. On 11/10/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,68,10/06/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2237500318,12/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/15/2021 in a 77 year old Female. On 12/30/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,83,12/15/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2289495522,12/16/2021,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/15/2021 in a 76 year old Female. On 12/16/2021, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,83,12/15/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2198119836,06/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/22/2021 in a 88 year old Female. On 6/24/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Female,39,12/22/2021,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2237500454,06/06/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/22/2021 in a 73 year old Female. On 6/6/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,98,12/22/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2237500475,10/19/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/22/2021 in a 74 year old Female. On 10/19/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Female,98,12/22/2021,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2440512160,01/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/12/2022 in a 88 year old Male. On 1/12/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Male,68,01/12/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2440512303,02/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/7/2022 in a 87 year old Female. On 2/8/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,59,02/07/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2047677916,02/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/2/2022 in a 81 year old Male. On 2/7/2022, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,90,02/02/2022,NI,2109,4614,2993,4755,4114;4119,3221,4315,NI,0
2198115373,05/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/28/2022 in a 73 year old Female. On 5/23/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,90,02/28/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2198115374,05/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/28/2022 in a 73 year old Female. On 5/21/2022, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,90,02/28/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2440513187,03/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/28/2022 in a 73 year old Female. On 3/4/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,90,02/28/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2237508108,10/25/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/28/2022 in a 82 year old Female. On 10/25/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,94,02/28/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2440513285,03/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 77 year old Female. On 3/5/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,85,03/02/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2198115617,03/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/14/2022 in a 79 year old Male. On 3/23/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Male,68,03/14/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2237508539,10/27/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/14/2022 in a 80 year old Male. On 10/27/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,68,03/14/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2440513653,03/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 69 year old Male. On 3/2/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Male,91,03/02/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2198115660,04/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 69 year old Male. On 4/22/2022, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Male,91,03/02/2022,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2237507946,05/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 69 year old Male. On 5/18/2022, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Male,91,03/02/2022,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2237507947,05/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 69 year old Male. On 5/18/2022, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Male,91,03/02/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2440514100,03/16/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/16/2022 in a 62 year old Male. On 3/16/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,62,Male,152,03/16/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2237508263,08/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/30/2022 in a 85 year old Female. On 8/18/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,87,03/30/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2237510174,12/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/11/2022 in a 100 year old Male. On 12/21/2022, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,100,Male,75,04/11/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2237510151,12/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/11/2022 in a 100 year old Male. On 12/3/2022, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,100,Male,75,04/11/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2198117289,04/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/11/2022 in a 99 year old Male. On 4/18/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,99,Male,75,04/11/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2237510173,11/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/11/2022 in a 100 year old Male. On 11/22/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,100,Male,75,04/11/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2237488282,07/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/4/2022 in a 80 year old Female. On 7/7/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,55,05/04/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2237510671,02/03/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/4/2022 in a 81 year old Female. On 2/3/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,55,05/04/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2698195138,06/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 96 year old Female. On 6/21/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,96,Female,59,06/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2477131599,07/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/11/2022 in a 87 year old Female. On 7/12/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,55,07/11/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2477132321,07/26/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/25/2022 in a 78 year old Female. On 7/26/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,96,07/25/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2477133362,08/11/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/10/2022 in a 85 year old Female. On 8/11/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,51,08/10/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2477133371,08/11/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/10/2022 in a 85 year old Female. On 8/11/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,51,08/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2477135131,09/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/26/2022 in a 71 year old Female. On 9/28/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Female,110,09/26/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2563620982,11/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/31/2022 in a 85 year old Female. On 11/3/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,58,10/31/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2563621003,11/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/31/2022 in a 85 year old Female. On 11/2/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,58,10/31/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2563623159,12/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/12/2022 in a 84 year old Female. On 12/14/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,72,12/12/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2563624081,12/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/28/2022 in a 78 year old Female. On 12/30/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,65,12/28/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776402509,09/06/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/6/2022 in a 77 year old Male. On 9/6/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Male,91,09/06/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2776395925,10/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/4/2022 in a 93 year old Female. On 10/4/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,59,10/04/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2776395938,10/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/4/2022 in a 93 year old Female. On 10/4/2022, Percutaneous Coronary Intervention was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Percutaneous Coronary Intervention was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,59,10/04/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2238489770,12/26/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/15/2022 in a 88 year old Female. On 12/26/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Female,53,12/15/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2776390955,01/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/10/2023 in a 81 year old Female. On 1/11/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,65,01/10/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2238483098,04/07/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/23/2023 in a 70 year old Female. On 4/7/2023, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,111,02/23/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2238483105,03/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/23/2023 in a 70 year old Female. On 3/26/2023, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,111,02/23/2023,NI,1834,4614,2993,4755,4114;4119,3221,4315,NI,0
2238483111,03/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/23/2023 in a 70 year old Female. On 3/26/2023, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,111,02/23/2023,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2238483112,04/03/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/23/2023 in a 70 year old Female. On 4/3/2023, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,111,02/23/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2124232693,04/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/23/2022 in a 73 year old Female. On 4/1/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,92,03/23/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2241270575,02/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/10/2022 in a 78 year old Male. On 2/17/2023, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Male,66,08/10/2022,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2241270576,01/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/10/2022 in a 77 year old Male. On 1/11/2023, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Male,66,08/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2241270584,02/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/10/2022 in a 78 year old Male. On 2/17/2023, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Male,66,08/10/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2736522383,01/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/5/2022 in a 85 year old Female. On 1/5/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,56,01/05/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2736522390,01/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/5/2022 in a 85 year old Female. On 1/5/2022, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,56,01/05/2022,NI,2513,4648,2993,4755,4114;4119,3221,4315,NI,0
2736522394,01/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/5/2022 in a 85 year old Female. On 1/5/2022, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,56,01/05/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2736522409,01/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/5/2022 in a 85 year old Female. On 1/5/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,56,01/05/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2736522411,01/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/5/2022 in a 85 year old Female. On 1/5/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,56,01/05/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2736543646,04/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/22/2022 in a 85 year old Male. On 4/24/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,82,04/22/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778749790,07/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/22/2022 in a 81 year old Female. On 7/2/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,77,06/22/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2653967627,12/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/29/2022 in a 85 year old Female. On 12/30/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,65,12/29/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2653967628,12/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/29/2022 in a 85 year old Female. On 12/30/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,65,12/29/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2676799543,10/11/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/11/2022 in a 83 year old Male. On 10/11/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,76,10/11/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2676799552,10/13/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/11/2022 in a 83 year old Male. On 10/13/2022, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,76,10/11/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2404423258,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/30/2022 in a 76 year old Male. On 3/30/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Male,125,03/30/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2404423285,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/30/2022 in a 76 year old Male. On 3/30/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Male,125,03/30/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2404423286,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/30/2022 in a 76 year old Male. On 3/30/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Male,125,03/30/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2443742869,07/06/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/6/2022 in a 84 year old Female. On 7/6/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,58,07/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2241175182,12/27/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/23/2022 in a 88 year old Male. On 12/27/2022, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Male,83,08/23/2022,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2778763805,09/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/6/2022 in a 74 year old Female. On 9/8/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Female,102,09/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772793188,08/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 75 year old Female. On 8/24/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Female,117,08/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772793121,08/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 83 year old Male. On 8/24/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,84,08/24/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772793124,08/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 83 year old Male. On 8/29/2022, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,84,08/24/2022,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2772793149,08/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 83 year old Male. On 8/29/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,84,08/24/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772793148,08/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 83 year old Male. On 8/24/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,84,08/24/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772793151,08/29/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 83 year old Male. On 8/29/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,84,08/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772793150,08/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 83 year old Male. On 8/24/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,84,08/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772793308,08/25/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 87 year old Female. On 8/25/2022, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,08/24/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2772793324,08/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 87 year old Female. On 8/24/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,08/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772793330,08/25/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 87 year old Female. On 8/25/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,08/24/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772793332,08/25/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/24/2022 in a 87 year old Female. On 8/25/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,08/24/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2109196860,03/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/28/2022 in a 86 year old Male. On 3/28/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,96,01/28/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2637550143,02/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/16/2022 in a 82 year old Female. On 2/18/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,87,02/16/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504936642,06/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/8/2022 in a 77 year old Female. On 6/8/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,85,06/08/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2504936645,06/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/8/2022 in a 77 year old Female. On 6/8/2022, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,85,06/08/2022,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2504936668,06/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/8/2022 in a 77 year old Female. On 6/8/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,85,06/08/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2504936670,06/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/8/2022 in a 77 year old Female. On 6/8/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,85,06/08/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504937878,06/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 78 year old Female. On 6/20/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,134,06/20/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2504937905,06/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 78 year old Female. On 6/20/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,134,06/20/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2504937906,06/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/20/2022 in a 78 year old Female. On 6/20/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,134,06/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2504927796,08/19/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/19/2022 in a 74 year old Male. On 8/19/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,93,08/19/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2504927886,08/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/22/2022 in a 82 year old Male. On 8/24/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Male,75,08/22/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2167578188,01/07/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/14/2022 in a 89 year old Female. On 1/7/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,52,11/14/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2704045120,11/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/14/2022 in a 89 year old Female. On 11/14/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,52,11/14/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2704045121,11/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/14/2022 in a 89 year old Female. On 11/14/2022, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,52,11/14/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2231642727,08/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/22/2022 in a 73 year old Female. On 8/26/2023, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,62,07/22/2022,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2504935358,05/27/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/25/2022 in a 86 year old Male. On 5/27/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,76,05/25/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2167581220,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/25/2023 in a 83 year old Male. On 2/1/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,73,01/25/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2332451402,03/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/17/2022 in a 85 year old Female. On 3/22/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,53,03/17/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2465623591,06/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/31/2022 in a 88 year old Female. On 6/1/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Female,45,05/31/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2209722825,08/14/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/5/2022 in a 92 year old Female. On 8/14/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,52,07/05/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2501131337,09/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/8/2022 in a 68 year old Female. On 9/8/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,68,Female,61,09/08/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2501131343,09/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/8/2022 in a 68 year old Female. On 9/8/2022, Device Migration was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Migration was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,68,Female,61,09/08/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2501131352,09/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/8/2022 in a 68 year old Female. On 9/8/2022, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,68,Female,61,09/08/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2209716984,10/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/8/2022 in a 68 year old Female. On 10/4/2022, Stroke - Undetermined was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Undetermined was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,68,Female,61,09/08/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2485897943,08/10/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/9/2022 in a 94 year old Female. On 8/10/2022, Device Related Event - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Related Event - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Female,50,08/09/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2485897950,08/10/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/9/2022 in a 94 year old Female. On 8/10/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Female,50,08/09/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2501136722,12/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/20/2022 in a 79 year old Female. On 12/23/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Female,56,12/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2707656610,04/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/18/2023 in a 88 year old Female. On 4/20/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Female,60,04/18/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2707656661,04/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/18/2023 in a 86 year old Male. On 4/20/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,72,04/18/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2576893006,03/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/18/2022 in a 74 year old Female. On 3/21/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Female,99,03/18/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
1835956383,03/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 78 year old Female. On 3/15/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,69,03/02/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
1835956387,03/09/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/2/2022 in a 78 year old Female. On 3/9/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,69,03/02/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2485079193,07/16/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/13/2022 in a 72 year old Female. On 7/16/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Female,68,07/13/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2485079652,07/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/20/2022 in a 70 year old Female. On 7/20/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Female,54,07/20/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2485080689,09/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/6/2022 in a 72 year old Male. On 9/7/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Male,108,09/06/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2576925276,12/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/14/2022 in a 83 year old Female. On 12/15/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,57,12/14/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2775181306,03/14/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/14/2023 in a 87 year old Male. On 3/14/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,91,03/14/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2775178236,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/1/2023 in a 79 year old Male. On 5/1/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Male,59,05/01/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2775179704,06/28/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/28/2023 in a 81 year old Female. On 6/28/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,66,06/28/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2775178042,04/21/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/21/2023 in a 70 year old Male. On 4/21/2023, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Male,134,04/21/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2775178070,04/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 4/21/2023 in a 70 year old Male. On 4/22/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,70,Male,134,04/21/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2159970109,06/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/14/2022 in a 76 year old Female. On 6/24/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,105,02/14/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2159972870,12/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/21/2022 in a 84 year old Female. On 12/2/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,84,Female,64,02/21/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2302800104,02/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 2/28/2022 in a 83 year old Female. On 2/28/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,75,02/28/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2420613702,07/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/18/2022 in a 82 year old Male. On 7/18/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Male,78,07/18/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2420613729,07/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/18/2022 in a 82 year old Male. On 7/18/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Male,78,07/18/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2159670258,09/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/8/2022 in a 89 year old Male. On 9/21/2022, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Male,55,08/08/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2420614764,08/09/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/8/2022 in a 89 year old Male. On 8/9/2022, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Male,55,08/08/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2420614780,08/09/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/8/2022 in a 89 year old Male. On 8/9/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Male,55,08/08/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2159973372,09/13/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/6/2022 in a 89 year old Female. On 9/13/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,83,09/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2505057587,11/09/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/8/2022 in a 90 year old Female. On 11/9/2022, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Female,84,11/08/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2505059753,12/15/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/13/2022 in a 83 year old Female. On 12/15/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,93,12/13/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2664076037,01/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/17/2023 in a 94 year old Female. On 1/17/2023, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Female,60,01/17/2023,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2664078649,03/07/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/6/2023 in a 96 year old Female. On 3/7/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,96,Female,66,03/06/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234452904,12/16/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/8/2022 in a 76 year old Female. On 12/16/2022, ICD was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of ICD was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,67,12/08/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2305405981,03/30/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/29/2022 in a 87 year old Female. On 3/30/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,71,03/29/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2232828798,08/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 3/29/2022 in a 87 year old Female. On 8/1/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,71,03/29/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2226598928,05/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/4/2022 in a 71 year old Male. On 5/24/2022, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Male,91,05/04/2022,NI,1834,4614,2993,4755,4114;4119,3221,4315,NI,0
2226598934,05/24/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 5/4/2022 in a 71 year old Male. On 5/24/2022, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Male,91,05/04/2022,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
2772837492,06/01/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/1/2022 in a 89 year old Female. On 6/1/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,67,06/01/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234172254,11/11/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 6/15/2022 in a 81 year old Female. On 11/11/2022, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,72,06/15/2022,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2226597851,08/17/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/6/2022 in a 81 year old Male. On 8/17/2022, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,73,07/06/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2226597852,08/25/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/6/2022 in a 81 year old Male. On 8/25/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,73,07/06/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772835766,07/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 7/20/2022 in a 91 year old Female. On 7/20/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,52,07/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772835951,08/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/3/2022 in a 78 year old Female. On 8/3/2022, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,86,08/03/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2772836108,08/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/17/2022 in a 81 year old Male. On 8/18/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Male,72,08/17/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772834835,11/02/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/2/2022 in a 89 year old Female. On 11/2/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,57,11/02/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772835405,12/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/21/2022 in a 74 year old Male. On 12/21/2022, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Male,108,12/21/2022,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
1991123406,03/09/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/28/2022 in a 76 year old Male. On 3/9/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Male,126,01/28/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2238435448,08/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/2/2022 in a 68 year old Female. On 8/4/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,68,Female,106,08/02/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2776357952,09/20/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/20/2022 in a 69 year old Female. On 9/20/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Female,82,09/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2238433329,09/25/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/20/2022 in a 69 year old Female. On 9/25/2022, Stroke - Undetermined was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Undetermined was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Female,82,09/20/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2776357744,08/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/23/2022 in a 65 year old Male. On 8/23/2022, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,65,Male,162,08/23/2022,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2776357746,08/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/23/2022 in a 65 year old Male. On 8/23/2022, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,65,Male,162,08/23/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776357750,08/23/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 8/23/2022 in a 65 year old Male. On 8/23/2022, Device Migration was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Migration was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,65,Male,162,08/23/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2778169844,09/21/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 9/20/2022 in a 75 year old Female. On 9/21/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Female,76,09/20/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778164590,10/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/4/2022 in a 93 year old Male. On 10/5/2022, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Male,79,10/04/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2778164593,10/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/4/2022 in a 93 year old Male. On 10/5/2022, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Male,79,10/04/2022,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2240437835,10/12/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/4/2022 in a 93 year old Male. On 10/12/2022, Stroke - Undetermined was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Undetermined was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Male,79,10/04/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2778164616,10/05/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 10/4/2022 in a 93 year old Male. On 10/5/2022, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Male,79,10/04/2022,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2240435388,01/03/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/7/2022 in a 88 year old Female. On 1/3/2023, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Female,58,12/07/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2778162060,12/28/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/21/2022 in a 78 year old Female. On 12/28/2022, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,61,12/21/2022,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2778162076,12/22/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 12/21/2022 in a 78 year old Female. On 12/22/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,61,12/21/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2230050561,02/03/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2022 in a 75 year old Male. On 2/3/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Male,104,01/04/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2768967197,01/04/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/4/2022 in a 82 year old Female. On 1/4/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,66,01/04/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2768967334,01/18/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/18/2022 in a 87 year old Female. On 1/18/2022, Device Migration was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Device Migration was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,01/18/2022,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2230050747,03/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/18/2022 in a 87 year old Female. On 3/7/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,01/18/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2236880541,03/07/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/18/2022 in a 87 year old Female. On 3/7/2022, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,84,01/18/2022,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2775322907,11/08/2022,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 11/8/2022 in a 90 year old Female. On 11/8/2022, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Female,58,11/08/2022,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2775318947,01/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Portico was implanted on 1/24/2023 in a 83 year old Female. On 1/24/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Portico could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Female,82,01/24/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778310871,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 90 year old Female. On 5/1/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Female,77,05/01/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2763569749,03/02/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/2/2023 in a 76 year old Female. On 3/2/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,83,03/02/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2775320580,03/14/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/14/2023 in a 81 year old Female. On 3/14/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,67,03/14/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2778690511,04/04/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/4/2023 in a 94 year old Male. On 4/4/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Male,100,04/04/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2763570728,03/09/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/9/2023 in a 92 year old Female. On 3/9/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,64,03/09/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2763572195,03/16/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/16/2023 in a 80 year old Female. On 3/16/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,84,03/16/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2778690800,04/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/11/2023 in a 87 year old Male. On 4/11/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,76,04/11/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2778310872,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 90 year old Female. On 5/1/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Female,77,05/01/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770238103,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2763569750,03/02/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/2/2023 in a 76 year old Female. On 3/2/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,76,Female,83,03/02/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778690512,04/04/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/4/2023 in a 94 year old Male. On 4/4/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Male,100,04/04/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2763570729,03/09/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/9/2023 in a 92 year old Female. On 3/9/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,64,03/09/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2763572196,03/16/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/16/2023 in a 80 year old Female. On 3/16/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,84,03/16/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778690801,04/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/11/2023 in a 87 year old Male. On 4/11/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,76,04/11/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770237260,05/05/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/3/2023 in a 69 year old Male. On 5/5/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Male,85,05/03/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772743528,02/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/20/2023 in a 86 year old Female. On 2/22/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Female,70,02/20/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2775320427,03/14/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/14/2023 in a 63 year old Female. On 3/14/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,63,Female,81,03/14/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2768805776,03/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/23/2023 in a 72 year old Female. On 3/24/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,72,Female,83,03/23/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772700498,04/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 73 year old Female. On 4/11/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,106,04/06/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770235917,04/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/17/2023 in a 80 year old Male. On 4/17/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,94,04/17/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2770235916,04/25/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/17/2023 in a 80 year old Male. On 4/25/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,94,04/17/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2770238077,05/28/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/28/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2770238078,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2778690779,04/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/11/2023 in a 87 year old Male. On 4/11/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,76,04/11/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2770238074,05/25/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/25/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2770238075,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2704112417,02/10/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/9/2023 in a 88 year old Male. On 2/10/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Male,78,02/09/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2770238069,05/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/22/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2238188124,03/29/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/23/2023 in a 78 year old Female. On 3/29/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,66,03/23/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2778690484,04/04/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/4/2023 in a 94 year old Male. On 4/4/2023, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,94,Male,100,04/04/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2770238079,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,2513,4648,2993,4755,4114;4119,3221,4315,NI,0
2770238081,05/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/24/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770238082,05/16/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/16/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770238083,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770238080,05/25/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/25/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2775320556,03/14/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/14/2023 in a 81 year old Female. On 3/14/2023, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,67,03/14/2023,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2770238084,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Coronary Artery Compression was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Coronary Artery Compression was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,2422,4624,2993,4755,4114;4119,3221,4315,NI,0
2770238094,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Percutaneous Coronary Intervention was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Percutaneous Coronary Intervention was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770238101,05/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/15/2023 in a 60 year old Male. On 5/15/2023, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,60,Male,121,05/15/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2234047949,03/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/16/2023 in a 80 year old Female. On 3/17/2023, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,84,03/16/2023,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2778690698,04/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/11/2023 in a 74 year old Female. On 4/11/2023, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,74,Female,111,04/11/2023,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772744496,03/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/23/2023 in a 89 year old Male. On 3/24/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Male,102,03/23/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772744551,03/23/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/23/2023 in a 88 year old Female. On 3/23/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,88,Female,50,03/23/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2238189948,04/29/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/11/2023 in a 81 year old Female. On 4/29/2023, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,86,04/11/2023,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2238189950,04/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/11/2023 in a 81 year old Female. On 4/17/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,86,04/11/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778787406,04/21/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/19/2023 in a 86 year old Female. On 4/21/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Female,58,04/19/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778787410,04/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/19/2023 in a 86 year old Female. On 4/20/2023, Device Migration was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Migration was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Female,58,04/19/2023,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2778787419,04/21/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/19/2023 in a 86 year old Female. On 4/21/2023, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Female,58,04/19/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2766660692,03/08/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/8/2023 in a 81 year old Female. On 3/8/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,72,03/08/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2766660694,03/08/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/8/2023 in a 81 year old Female. On 3/8/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,81,Female,72,03/08/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2766660301,02/10/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/8/2023 in a 87 year old Male. On 2/10/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,63,02/08/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2226891716,03/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/8/2023 in a 87 year old Male. On 3/20/2023, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,63,02/08/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2766660322,02/16/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/8/2023 in a 87 year old Male. On 2/16/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,63,02/08/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2766660328,02/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/8/2023 in a 87 year old Male. On 2/17/2023, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,63,02/08/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2226891735,03/21/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/8/2023 in a 87 year old Male. On 3/21/2023, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,63,02/08/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2760452434,03/18/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/17/2023 in a 85 year old Female. On 3/18/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,53,03/17/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2760452446,03/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/17/2023 in a 85 year old Female. On 3/20/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,53,03/17/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776192579,05/04/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/4/2023 in a 71 year old Female. On 5/4/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Female,130,05/04/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2776192580,05/04/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/4/2023 in a 71 year old Female. On 5/4/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Female,130,05/04/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776192382,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 79 year old Female. On 5/1/2023, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Female,97,05/01/2023,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2772737397,04/10/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/10/2023 in a 85 year old Female. On 4/10/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,64,04/10/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772737398,04/10/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/10/2023 in a 85 year old Female. On 4/10/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Female,64,04/10/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772702281,04/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/13/2023 in a 96 year old Male. On 4/17/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,96,Male,62,04/13/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2238657720,04/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/24/2023 in a 75 year old Female. On 4/26/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Female,92,03/24/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2240771688,04/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/28/2023 in a 75 year old Female. On 4/26/2023, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,75,Female,63,03/28/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2770235517,05/02/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/24/2023 in a 67 year old Female. On 5/2/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,67,Female,61,04/24/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2707659026,05/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/16/2023 in a 95 year old Female. On 5/17/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,95,Female,68,05/16/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2707659038,05/18/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/16/2023 in a 95 year old Female. On 5/18/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,95,Female,68,05/16/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772738107,04/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/24/2023 in a 71 year old Male. On 4/24/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,71,Male,127,04/24/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772737795,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 86 year old Male. On 5/1/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,74,05/01/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2772737799,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 86 year old Male. On 5/1/2023, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,74,05/01/2023,NI,1884,4648,2993,4755,4114;4119,3221,4315,NI,0
2772737823,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 86 year old Male. On 5/1/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,74,05/01/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772737824,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 86 year old Male. On 5/1/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,86,Male,74,05/01/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772737869,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 83 year old Male. On 5/1/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,95,05/01/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2772737870,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/1/2023 in a 83 year old Male. On 5/1/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,95,05/01/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2698187245,02/03/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 1/31/2023 in a 92 year old Female. On 2/3/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,92,Female,51,01/31/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2698187420,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 91 year old Female. On 2/1/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,70,02/01/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2698187423,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 91 year old Female. On 2/1/2023, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,70,02/01/2023,NI,2513,4648,2993,4755,4114;4119,3221,4315,NI,0
2698187424,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 91 year old Female. On 2/1/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,70,02/01/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2698187442,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 91 year old Female. On 2/1/2023, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,70,02/01/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2237882330,06/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/30/2023 in a 85 year old Male. On 6/1/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,71,05/30/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2237506224,02/04/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 77 year old Female. On 2/4/2023, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,74,02/01/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2698187488,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 77 year old Female. On 2/1/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,74,02/01/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2698187489,02/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 2/1/2023 in a 77 year old Female. On 2/1/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Female,74,02/01/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2662717780,06/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/31/2023 in a 80 year old Male. On 6/1/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,70,05/31/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2662717796,06/05/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/31/2023 in a 80 year old Male. On 6/5/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,70,05/31/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2662717799,06/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/31/2023 in a 80 year old Male. On 6/1/2023, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Male,70,05/31/2023,NI,1770,4648,2993,4755,4114;4119,3221,4315,NI,0
2776082799,04/09/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 89 year old Female. On 4/9/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,41,04/06/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2776082804,04/06/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 89 year old Female. On 4/6/2023, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,41,04/06/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2776082807,04/06/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 89 year old Female. On 4/6/2023, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,41,04/06/2023,NI,2513,4648,2993,4755,4114;4119,3221,4315,NI,0
2776082808,04/06/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 89 year old Female. On 4/6/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,41,04/06/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776082814,04/08/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 89 year old Female. On 4/8/2023, Device Thrombosis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Thrombosis was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,41,04/06/2023,NI,4440,4648,4001,4755,4114;4119,3221,4315,NI,0
2776082815,04/09/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 89 year old Female. On 4/9/2023, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Female,41,04/06/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776082868,04/07/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/6/2023 in a 87 year old Female. On 4/7/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Female,94,04/06/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776083544,04/17/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/13/2023 in a 79 year old Female. On 4/17/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,79,Female,106,04/13/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776193761,06/12/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/12/2023 in a 78 year old Female. On 6/12/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,59,06/12/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2776193762,06/12/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/12/2023 in a 78 year old Female. On 6/12/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,78,Female,59,06/12/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772739231,05/25/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/25/2023 in a 77 year old Male. On 5/25/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,77,Male,103,05/25/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2240773218,06/14/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/8/2023 in a 80 year old Female. On 6/14/2023, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,82,05/08/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778480917,05/09/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/8/2023 in a 80 year old Female. On 5/9/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,80,Female,82,05/08/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2707661602,06/22/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/20/2023 in a 85 year old Male. On 6/22/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,71,06/20/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2234216973,07/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/7/2023 in a 69 year old Male. On 7/15/2023, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,69,Male,110,06/07/2023,NI,1969,4614,2993,4755,4114;4119,3221,4315,NI,0
2698190412,03/08/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 3/8/2023 in a 89 year old Male. On 3/8/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,89,Male,89,03/08/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772740042,06/07/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/7/2023 in a 96 year old Female. On 6/7/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,96,Female,73,06/07/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2778161526,05/31/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/31/2023 in a 82 year old Female. On 5/31/2023, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,127,05/31/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2778161552,05/31/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/31/2023 in a 82 year old Female. On 5/31/2023, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,127,05/31/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2778161554,05/31/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/31/2023 in a 82 year old Female. On 5/31/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,127,05/31/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772740475,06/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/19/2023 in a 82 year old Female. On 6/19/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,74,06/19/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2772740477,06/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/19/2023 in a 82 year old Female. On 6/19/2023, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,74,06/19/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2772740480,06/19/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/19/2023 in a 82 year old Female. On 6/19/2023, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,82,Female,74,06/19/2023,NI,4580,4648,1395,4755,4114;4119,3221,4315,NI,0
2670562700,06/29/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/28/2023 in a 87 year old Male. On 6/29/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,87,Male,97,06/28/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778313124,04/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/24/2023 in a 93 year old Female. On 4/24/2023, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,52,04/24/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2778313151,04/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/24/2023 in a 93 year old Female. On 4/24/2023, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,52,04/24/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2778313152,04/24/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/24/2023 in a 93 year old Female. On 4/24/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,52,04/24/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2771387711,06/12/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/12/2023 in a 85 year old Male. On 6/12/2023, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,51,06/12/2023,NI,1762,4614,2993,4755,4114;4119,3221,4315,NI,0
2771387720,06/15/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/12/2023 in a 85 year old Male. On 6/15/2023, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,85,Male,51,06/12/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2240541781,05/01/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 4/26/2023 in a 90 year old Female. On 5/1/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,90,Female,57,04/26/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2778482500,06/05/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/5/2023 in a 73 year old Female. On 6/5/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,95,06/05/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2240768565,07/02/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/21/2023 in a 95 year old Male. On 7/2/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,95,Male,79,06/21/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2240768192,06/26/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/1/2023 in a 73 year old Female. On 6/26/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,73,Female,86,06/01/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776388167,05/14/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/11/2023 in a 93 year old Female. On 5/14/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,58,05/11/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2776388168,05/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/11/2023 in a 93 year old Female. On 5/11/2023, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,58,05/11/2023,NI,1888,4648,2993,4755,4114;4119,3221,4315,NI,0
2776388194,05/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/11/2023 in a 93 year old Female. On 5/11/2023, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,58,05/11/2023,NI,4580,4648,2993,4755,4114;4119,3221,4315,NI,0
2776388196,05/11/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/11/2023 in a 93 year old Female. On 5/11/2023, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,93,Female,58,05/11/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2776089275,06/20/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/15/2023 in a 83 year old Male. On 6/20/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,64,06/15/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2776089296,06/16/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/15/2023 in a 83 year old Male. On 6/16/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,83,Male,64,06/15/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2763881971,06/13/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 6/9/2023 in a 95 year old Female. On 6/13/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,95,Female,71,06/09/2023,NI,4580,4624,2993,4755,4114;4119,3221,4315,NI,0
2229638422,07/05/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/30/2023 in a 91 year old Female. On 7/5/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,75,05/30/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NI,0
2229638423,07/05/2023,01/30/2024,11/17/2023,Portico Transcatheter Aortic Valve,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 5/30/2023 in a 91 year old Female. On 7/5/2023, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported. A more comprehensive assessment could not be performed as no additional information was received for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. There is no indication of a product quality issue with regards to manufacture, design, or labeling.",No Information,91,Female,75,05/30/2023,NI,4580,4607,3190,4755,4114;4119,3221,4315,NI,0
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