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

Model Number	TFGT-19A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning 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 an unknown date, a 19mm trifecta gt valve was implanted.On an unknown date, the valve was explanted due to unknown reasons.The patient was reported to be stable and recovering.
Additional Manufacturer Narrative
Explant of trifecta valve due to an unknown reason was reported.The investigation found calcifications on all leaflets.There was fibrous thickening on all leaflets and circumferential fibrous pannus ingrowth on the inflow and outflow surfaces of leaflet 2.Leaflets 1 and 2 were torn, tears were associated with calcifications.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the exact reason for valve explant remains unknown, calcifications and pannus ingrowth could lead to a number of potential issues with valve functionality.

• 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: 21479644
• Report Number: 2135147-2025-00979
• Device Sequence Number: 3956740
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: (01)05415067018205(17)211112
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: TFGT-19A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 6234839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2017
• 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: Required Intervention
• Patient Sex: Unknown