MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number TFGT-21A

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/04/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 21mm trifecta gt valve was implanted in a patient.It was noted via echocardiogram, in (b)(6) 2023, that the valve had structural valve deterioration with a torn cusp, resulting in aortic regurgitation, symptoms of heart failure, and leg swelling.The valve was explanted on (b)(6) 2023 and a non-abbot device was implanted as a replacement.It was noted during explant that the 21mm trifecta gt valve also had torn leaflets.The patient was stable at the time of report.

Manufacturer Narrative

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

Manufacturer Narrative

Explant of the device due to structural valve deterioration (svd) resulting in aortic regurgitation, symptoms of heart failure, and leg swelling was reported.The investigation found that all three leaflets were torn.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence of infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of svd, which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear site and the cause of the leaflet tears could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18438145
• MDR Text Key: 331828467
• Report Number: 2135147-2024-00027
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• 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: 02/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-21A
• Device Lot Number: BR00025512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR