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

Model Number	TFGT-21A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/09/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2018, a 21mm trifecta gt valve was chosen for implant.It was then reported on (b)(6) 2024, a decision was made perform redo-surgical aortic valve replacement due to severe aortic regurgitation and other unspecified heart problems.During intraoperative investigation, it was observed one of the trifecta valve leaflets had completely torn away.The 21mm trifecta gt valve was explanted and replaced with a 23mm non-abbott valve.It was later reported the patient passed away on (b)(6) 2024.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

• 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 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 ; +1(651)756-5400
• MDR Report Key: 50940683
• Report Number: 2135147-2026-06610
• Device Sequence Number: 10759558
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: (01)05415067018212(17)210710
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 07/10/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 180385148
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2017
• 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: Death
• Patient Sex: Male