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

Model Number	PRT-29
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022,a 29mm portico valve was successfully implanted with mild-moderate paravalvular leak and it was thought that it would resolve over time as the valve settled into the anatomy.On (b)(6) 2022, the patient presented with dyspnea.An echocardiogram was performed and showed moderate central aortic regurgitation.A computed tomography (ct) done showed that that the valve frame looked constrained, which was not seen on post-implant echocardiogram and angiogram.The patient was scheduled for reintervention, however it has not been performed yet.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of mild paravalvular leak, moderate central aortic regurgitation and shortness of breath was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2022, a 29mm portico valve was successfully implanted with mild -moderate paravalvular leak and it was thought that it would resolve over time as the valve settled into the anatomy.The sizing of the valve was 80.3mm perimeter and area 504.4mm and the implant depth was 8mm ncc and lcc and there was there enough calcium distribution.The valve was heavily constrained on first deployment at around 2-3mm deployment with non uniform expansion.Therefore, they went deeper and got better valve expansion.On (b)(6) 2022, the patient presented with dyspnea.An echocardiogram was performed and showed moderate central aortic regurgitation.A computed tomography (ct) done showed that the valve frame looked constrained, which was not seen on post implant echocardiogram and angiogram.The patient is scheduled for reintervention, however it has not been performed yet.The patient was reported to be in stable condition.

• Brand Name: PORTICO
• 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: 15540225
• Report Number: 2135147-2022-01483
• Device Sequence Number: 7046541
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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 Expiration Date: 10/26/2024
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8222891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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: 83 YR
• Patient Sex: Unknown