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

Model Number	TFGT-A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	10/21/2022
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) 2016 a 19mm trifecta valve was implanted into a patient.Post-operatively, there was an increase in pressure difference noted, but no symptoms.On an unknown day in (b)(6) 2022, echocardiogram was performed and revealed severe aortic stenosis.On (b)(6) 2022, the trifecta valve was explanted and replaced with a 19mm non-abbott device.Visual inspection of the explanted valve revealed adhesions on 2 or 3 stent posts and leaflet sclerosis.The device cusp and stent on the post-non-coronary cusp (ncc) side were damaged during explant.The patient is reported to be stable.
Additional Manufacturer Narrative
Explant due to stenosis was reported.The investigation found that all three leaflets contained calcifications and were fibrously thickened.Leaflet 1 and 2 were torn.There was circumferential fibrous pannus ingrowth on the inflow and outflow of the valve.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.The pannus and calcifications noted could have contributed to the reported stenosis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15835177
• Report Number: 2135147-2022-02135
• Device Sequence Number: 5762513
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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: 2016
• 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): 02/03/2023

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: 08/31/2018
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5650137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2016
• 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: 73 YR
• Patient Sex: Male