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

Model Number PRT-29

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/04/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 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
• Type of Device: 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
• MDR Text Key: 302683799
• Report Number: 2135147-2022-01840
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LARGE FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, 8235051
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male