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

Catalog Number	TFGT-21A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Ischemia (1942); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2018, a 21 mm trifecta gt (tfgt-21a, serial#(b)(6)) valve was implanted successfully.Due to an enlarged annulus, the device was implanted more diagonally.On (b)(6) 2023, reintervention was performed due to aortic stenosis and regurgitation (asr).Due to severe calcification that affected valsalva, the valve was unable to function so it was explanted.A 21mm non-abbott valve was implanted in it's place.The patient experienced myocardial ischemia so they were placed on extracorporeal membrane oxygenation (ecmo) and an intra-aortic balloon pump (iabp).The patient is reported to be unstable.The physician thought the diagonal nature of the implant may have placed unusual stress on the device.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant of the device due to severe calcification that affected valsalva and rendered the valve dysfunctional was reported.The investigation found that the sewing cuff was removed, and all three leaflets were torn and had fibrous thickening.Calcifications were also present on all three leaflets which limited mobility.Leaflet 2 had two irregular tears in the cusp base, associated with calcifications.Leaflet 3 had marked fibrous thickening and was nearly completely replaced by calcified nodules.Leaflet 3 also had an irregular tear in the base of the cusp along the stent post shared with leaflet 2.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 cause of the tears could not be conclusively determined; however, the tears observed were associated with calcifications which 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 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: 18012538
• Report Number: 2135147-2023-04677
• Device Sequence Number: 12591162
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• 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: 2018
• Device Explanted Year: 2023
• 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): 11/15/2023

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: 05/28/2021
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6026715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2017
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male