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

Model Number	TFGT-A
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/11/2022
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 19mm trifecta gt valve was chosen for implant for an aortic valve replacement.During implant, a densely calcified native valve with a pointed orifice was found; the valve was successfully implanted.The surgery had no complications or deviation from the usual surgical technique.On (b)(6) 2022, a grade iii valvular insufficiency was found.Echocardiographic images were performed and evaluated, and the insufficiency of the prosthesis was determined to be valvular and not paravalvular.On (b)(6) 2022, the valve was explanted and a new 19mm trifecta gt valve was successfully implanted with no reported complications.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of inadequate coaptation of the leaflets was reported.No anomalies were noted to the valve and the leaflets, however functional testing at the time of manufacturing indicated the valve coapted properly upon closing but showed signs of flutter on one of the three leaflets upon opening.This test ensures proper leaflet coaptation and hemodynamic performance.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This was inclusive of a review of the manufacturing videos, which contained no evidence of damage seen on any of the leaflets.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Two images from the filed appeared to show a valve in closed position implanted inside the patient.
Event or Problem Description
It was reported that on (b)(6) 2022, a 19mm trifecta gt valve was chosen for implant for an aortic valve replacement.During implant, a densely calcified native valve with a pointed orifice was found; the valve was successfully implanted.The surgery had no complications or deviation from the usual surgical technique.On (b)(6) 2022, a grade iii valvular insufficiency was found.Echocardiographic images were performed and evaluated, and the insufficiency of the prosthesis was determined to be valvular and not paravalvular.On (b)(6) 2022, the valve was explanted and a new 19mm trifecta gt valve was successfully implanted with no reported complications.The patient was reported to be in stable condition.Subsequent to the previously filed report, additional information was received that the during the explant of the valve, it was noted that there was a lack of an adequate coaptation of the leaflets.There were no signs of thrombus, calcification, leaflet deformation, torn cusp, or general structural valve deterioration on the valve.The patient was reported to be fully recovered and discharged home.

• 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: 15393573
• Report Number: 2135147-2022-01074
• Device Sequence Number: 6463824
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/19/2022

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: 01/12/2024
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 7372988
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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 Age: 75 YR
• Patient Sex: Female