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

Model Number	TFGT-21A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a 21mm trifecta gt valve was implanted for valve replacement surgery.On (b)(6) 2024, the patient began experiencing shortness of breath and confirmed that the valve was leaking.A transcatheter aortic valve replacement (tavr) was performed through the femoral artery.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
An event of patient experiencing shortness of breath and central regurgitation after three years of trifecta valve implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The reported hospitalization and surgical intervention were due to a transcatheter aortic valve replacement.
Event or Problem Description
N/a.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 23889337
• Report Number: 2135147-2025-07699
• Device Sequence Number: 4706217
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: (01)05415067018212(17)241025
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P100029
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 10/25/2024
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 7739848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female