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

Model Number	TFGT-27A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2023, a 27mm trifecta gt aortic valve was implanted successful.On (b)(6) 2025, it was confirmed that the patient was experiencing structural valve deterioration in the form of valve leakage, which led to health issues shortly after implantation.Surgical intervention is scheduled for (b)(6).
Event or Problem Description
It was reported that on (b)(6) 2023, a 27mm trifecta gt aortic valve was implanted successful.On (b)(6) 2025, it was confirmed that the patient was experiencing structural valve deterioration in the form of valve leakage, which led to health issues shortly after implantation.Surgical intervention is scheduled for september.
Additional Manufacturer Narrative
An event of structural valve deterioration in the form of valve leakage approximately 2 years and 5 months post-implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, 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.The reported serious injury/illness/impairment was a result of case-specific circumstances as no intervention was reported.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: medical device problem code: component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 4118 type of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusion not yet available.

• 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 ; 6517565400
• MDR Report Key: 23058128
• Report Number: 2135147-2025-05208
• Device Sequence Number: 15828524
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: (01)05415067018243(17)251213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2025
• Device Model Number: TFGT-27A
• Device Catalogue Number: TFGT-27A
• Device Lot Number: BR00031373
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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
• Patient Sex: Unknown