MAUDE Adverse Event Report: ABBOTT MEDICAL PORTICO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	PRT-27
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported through a literature article, ¿valve embolization during transcatheter aortic valve implantation: incidence, risk factors and follow-up by computed tomography¿, a 84-year-old patient that had a 27mm portico valve implanted.Post implant the valve migrated after valve was released.The final transcatheter heart valve position was noted to be in the ascending aorta.A valve-in-valve was performed using a 23mm sapien 3.At 9 months follow up computerized tomography (ct) scan revealed upper crown protruding into the aortic wall.The article concluded tvem represents a rare complication of tavi.Follow up-ct found hypoattenuated leaflet thickening at embolized valve.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, ¿valve embolization during transcatheter aortic valve implantation: incidence, risk factors and follow-up by computed tomography¿, was reviewed.This research article aimed of this study was to analyze the incidence of transcatheter valve embolization and migration (tvem) in a large cohort of patients undergoing transcatheter aortic valve implantation (tavi) and to examine embolized valves by computed tomography (ct) late after tavi.This research article reported a case study 84-year-old female patient that had a 27mm portico valve implanted.Post implant the valve migrated after valve was released.The final transcatheter heart valve position was noted to be in the ascending aorta.A valve-in-valve was performed using a 23mm sapien ultra 3.At 2 months follow up computerized tomography (ct) scan revealed hypoattenuation.There was no leaflet thickening at embolized valve.The article concluded tvem represents a rare complication of tavi.Follow up-ct detected no pathological findings requiring intervention.[the primary and corresponding author of this article henryk dreger, md, 1medizinische klinik mit schwerpunkt kardiologie und angiologie, charité ¿ universitätsmedizin berlin, berlin, germany].

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17325959
• Report Number: 2135147-2023-03032
• Device Sequence Number: 5509761
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRT-27
• Device Catalogue Number: PRT-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female