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

Model Number	TFGT-23A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Angina (1710)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2022, a 23mm trifecta gt valve was implanted in the patient.The annular dimension of the native valve was 24mm (based on preoperative transthoracic echocardiogram (tte) data.On (b)(6) 2025, the patient experienced chest tightness, back pain, cold sweats, and chest pain.A routine echocardiographic evaluations were not performed; the symptoms prompted an echocardiogram, which led to the diagnosis of structural valve deterioration (svd).One of the leaflets had detached.The valve got explanted and a non-abbott valve was implanted.The patient was reported stable.
Additional Manufacturer Narrative
Explant about 3 years and 7 months post-implant due to structural valve deterioration and one detached leaflet was reported.The patient was presented with symptoms of chest tightness, back pain, cold sweats and chest pain.The valve was returned to abbott for investigation and found fibrous pannus ingrowth on the inflow surface of cusp 2.Cusps 2 and 3 were noted to be torn.The sewing cuff was intact.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 chest tightness, back pain, cold sweats and chest pain appear to be a cascading effect of the reported structural valve deterioration.The cause of the pannus formation could not be conclusively determined.The cause of the tear could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.The reported hospitalization and surgical intervention were results of case-specific circumstances as the patient was admitted and the valve was explanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23184389
• Report Number: 2135147-2025-05544
• Device Sequence Number: 18640030
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)240714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 12/18/2025

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: 07/14/2024
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: BR00025537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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 Sex: Unknown