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

Model Number	TFGT-23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Pleural Effusion (2010); Syncope/Fainting (4411)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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) 2019, a 23mm trifecta gt valve was implanted in the patient.On an unknown date in (b)(6) 2024, the patient began to feel numbness in the heart and difficulty in breathing.The patient got examined in (b)(6) 2024 and it was found that the trifecta valce had become so narrowed that it was borderline non-functional.A triplex examination showed the valve had deteriorated to a great extent and it was determined that it would need to be replaced.A new surgery of replacing the trifecta with a mechanical valve was scheduled for beginning of 2025.However, because of difficulty with breathing and fainting episodes, it was decided the surgery to take place on (b)(6) 2024.It was found that more than a litter of fluid had accumulated in the lungs due to the fact that the trifecta had worn out to such an extent that was essentially non-functional.An unknown size mechanical valve was implanted.The patient was reported stable.
Additional Manufacturer Narrative
An event of stenosis 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported stenosis could not be conclusively determined.The reported calcifications on valve could have contributed to the reported stenosis, however it could be confirmed as the valve was not received for examination.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2019, a 23mm trifecta gt valve was implanted in the patient.On an unknown date in (b)(6) 2024, the patient began to feel numbness in the heart and difficulty in breathing.The patient got examined in (b)(6) 2024 and it was found that the trifecta valce had become so narrowed that it was borderline non-functional.A triplex examination showed the valve had deteriorated to a great extent and it was determined that it would need to be replaced.A new surgery of replacing the trifecta with a mechanical valve was scheduled for beginning of 2025.However, because of difficulty with breathing and fainting episodes, it was decided the surgery to take place on (b)(6) 2024.It was found that more than a litter of fluid had accumulated in the lungs due to the fact that the trifecta had worn out to such an extent that was essentially non-functional.An unknown size mechanical valve was implanted.The patient was reported stable.

• 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: 23618889
• Report Number: 2135147-2025-06788
• Device Sequence Number: 10170093
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)221114
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 01/13/2026

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: 11/14/2022
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6763608
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male