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

Model Number	PRT-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 29mm non-abbott product was implanted that was unsuccessful with aortic regurgitation noted.A root enlargement was done when the 29mm non-abbott device was implanted.It was decided to proceed with a valve in valve procedure.A 29mm portico valve was then implanted in a valve in valve procedure.It was noted during the procedure that the device was not anchored very well due to no calcium in the implant location.During the post operative echocardiogram, a trivial leak was noted.On (b)(6) 2022, during a follow up echocardiogram, it was discovered that there was moderate aortic regurgitation and paravalvular leak.The valve had migrated and was now too deep.An additional valve will need to be implanted, but is not scheduled yet.No additional information was provided.
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 moderate aortic regurgitation, migration and paravalvular leak 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.
Event or Problem Description
It was reported that on (b)(6) 2022, a 29mm non-abbott product was implanted that was unsuccessful with aortic regurgitation noted.A root enlargement was done when the 29mm non-abbott device was implanted.It was decided to proceed with a valve in valve procedure.A 29mm portico valve was then implanted in a valve in valve procedure.It was noted during the procedure that the device was not anchored very well due to no calcium in the implant location.During the post operative echocardiogram, a trivial leak was noted.On 04 october 2022, during a follow up echocardiogram, it was discovered that there was moderate aortic regurgitation and paravalvular leak.The valve had migrated and was now too deep.An additional valve will need to be implanted, but is not scheduled yet.

• 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: 15693386
• Report Number: 2135147-2022-01840
• Device Sequence Number: 15293663
• 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: 09/30/2022
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8155042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LARGE FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, 8235051
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male