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

Model Number	TFGT-25A
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Insufficient Information (4580)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2018, a 25mm trifecta gt valve was implanted in the patient.The patient was having another surgery.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2018, a 25mm trifecta gt valve was implanted in the patient.No further information was provided.Limited information was provided with no hazardous situation or patient harm reported.A returned device assessment 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.Based on the information received, the cause of the reported incident could not be conclusively.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2018, a 25 mm trifecta gt valve was implanted in the patient.No further information was provided.Limited information was provided with no hazardous situation or patient harm reported.A returned device assessment 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.Based on the information received, the cause of the reported incident could not be conclusively.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2018, a 25 mm trifecta gt valve was implanted in the patient.On an unknown date, shortness of breath (sob) was noted, and valve output reportedly decreased significantly.A decision was made to replace the valve.On (b)(6) 2025, the valve was explanted and aunknown valve was implanted.The physician confirmed the explanted valve was not functioning at all.After the procedure, the patient returned to the emergency room (er) due to complications (bleeding and fluid in drain tube).The patient was currently in cardiac rehab post cardioversion to address atrial fibrillation (a-fib).No additional information was provided.

• 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: 21218652
• Report Number: 2135147-2025-00372
• Device Sequence Number: 21017966
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: (01)05415067018236(17)220127
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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): 04/22/2025

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: 01/27/2022
• Device Model Number: TFGT-25A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: BR00015297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/20/2025; 04/02/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/25/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2018
• 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: 71 YR
• Patient Sex: Male