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

Model Number	PRT-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Angina (1710)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6).It was reported that on 07 june 2021, a 23mm portico valve was successfully implanted in a patient using a small flexnav delivery system.The patient had remained hemodynamically stable throughout the procedure.There had been no difficulty experienced implanting the valve.There was no clinically significant delay in procedure reported.It was noted post-operation that the patient had a groin hematoma and an increased hemoglobin levels due to bleeding from the contralateral (non-tavi) puncture side.The decision was made to transfuse the patient with 2 units of of red blood cells containing saline, adenine, glucose and mannitol (sagm).On (b)(6), 2023, the patient was re-admitted to the hospital due to low hemoglobin levels and light chest pain.The patient was again transfused with red blood cells.The cause of the patient's light chest pain is unknown, but a possible partial coronary obstruction can not be excluded.The cause of the patient's low hemoglobin was due to the minor groin hematoma.It was noted that on (b)(6), 2021, the patient passed away under surgery for a coronary artery bypass graft due to 75% reversible ischemia of the left ventricle myocardium.It was also noted via rubidium positron emission tomography (pet), that there was a very large reversible perfusion defect involving the entire anterior and lateral wall and adjacent septum and rear wall.It was confirmed via coronary angiography, that there was mildly atheromatous of the right coronary artery without stenosis and retrograde collaterals from the posterior descending artery to the left anterior descending artery.It was also noted that there was obstruction of the left main coronary artery caused by cusp material of an existing unknown valve, 5 months post valve-in-valve procedure.There is no allegation of malfunction against the 23mm portico valve or procedure and the death is not attributed to the 23mm portico valve or procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of chest pain four days after the portico valve was implanted was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the cause of the chest pain was unknown but that it could be due to partial coronary obstruction, which had occurred due to obstruction of the left main coronary by the leaflet of the previously implanted surgical valve which the portico valve was implanted inside.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - impact code: code 4641 removed.
Event or Problem Description
Clinical information: (b)(6) - portico valve-in-valve retrospective registry, patient site id: (b)(6).It was reported that on 07 june 2021, a 23mm portico valve was successfully implanted in a patient using a small flexnav delivery system.The patient had remained hemodynamically stable throughout the procedure.There had been no difficulty experienced implanting the valve, but a post-implant dilation was performed.There was no clinically significant delay in procedure reported.It was noted post-operation that the patient had a groin hematoma and an increased hemoglobin levels due to bleeding from the contralateral (non-tavi) puncture side.The decision was made to transfuse the patient with 2 units of of red blood cells containing saline, adenine, glucose and mannitol (sagm).On (b)(6) 2023, the patient was re-admitted to the hospital due to low hemoglobin levels and light chest pain.The patient was again transfused with red blood cells.The cause of the patient's light chest pain is unknown, but a possible partial coronary obstruction can not be excluded.The cause of the patient's low hemoglobin was due to the minor groin hematoma.It was noted that on (b)(6) 2021, the patient passed away under surgery for a coronary artery bypass graft due to 75% reversible ischemia of the left ventricle myocardium.It was also noted via rubidium positron emission tomography (pet), that there was a very large reversible perfusion defect involving the entire anterior and lateral wall and adjacent septum and rear wall.It was confirmed via coronary angiography, that there was mild atheromatous of the right coronary artery without stenosis and retrograde collaterals from the posterior descending artery to the left anterior descending artery.It was also noted 5 months post valve-in-valve procedure, that there was a partial obstruction of the left main coronary artery caused by cusp material of a 21mm trifecta valve that was implanted on an unknown date.The left leaflet of the 21mm trifecta valve was pushed against side by the 23mm portico valve resulting the obstruction of the left main coronary artery.There is no allegation of malfunction against the 23mm portico valve or procedure and the death is not attributed to the 23mm portico valve or procedure.

• 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: 17356700
• Report Number: 2135147-2023-03116
• Device Sequence Number: 5152047
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 7651732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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: Hospitalization
• Patient Sex: Unknown