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

Model Number	TFGT-A
Medical Device Problem Codes	Degraded (1153); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/31/2023
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) 2019, a 25mm trifecta valve was implanted.On (b)(6) 2023, the patient experienced shortness of breath.It was determined that the patient needed a new valve due to aortic insufficiency.The device was explanted and replaced with a 25mm epic plus.The patient is reported to be discharged.
Additional Manufacturer Narrative
Explant due to shortness of breath was reported.The investigation found that the calcifications on all the leaflets and leaflets 2 and 3 were torn.All leaflets have fibrous thickening and contain coalesced, calcified nodules, which distort and efface the normal cusp architecture, and leaflets were torn (2&3) associated with calcifications.No inflammation was present.However, the calcification on the leaflets may have caused the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear could not be conclusively determined.However, the calcification 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.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 #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: 16799516
• Report Number: 2135147-2023-01783
• Device Sequence Number: 19642681
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 07/05/2023

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: 09/12/2022
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 6671523
• 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: 04/01/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2018
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female