MAUDE Adverse Event Report: ABBOTT MEDICAL Trifecta¿ GT Valve; Heart-Valve, Non-Allograft Tissue

Model Number	TFGT-21A
Medical Device Problem Codes	Perivalvular Leak (1457); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B3: date of event is an estimated date.
Event or Problem Description
It was reported that on (b)(6) 2019, a 21mm trifecta gt valve was implanted.On an unknown date, leaking valve was observed.The valve remains implanted.No additional information was provided.
Additional Manufacturer Narrative
An event of perivalvular leak (pvl), aortic valve insufficiency/regurgitation, and minor injury/ illness / impairment was reported.A more comprehensive assessment of the valve could not be performed as the device remains implanted and was not returned for analysis.No further details were provided regarding the event or procedure.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 available information, the cause of the reported event could not be conclusively determined.The reported minor injury/illness/impairment was a result of case specific circumstance as no treatment was provided for the pvl.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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 ; +1(651)756-5400
• MDR Report Key: 21610709
• Report Number: 2135147-2025-01321
• Device Sequence Number: 18046068
• Product Code: LWR
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 08/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6479938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 07/21/2026
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/22/2025; 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2018
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Male