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

Catalog Number	TFGT-21A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/17/2024
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 21mm trifecta gt final package was implanted in a patient along with artificial blood vessel (non-abbott product: j graft) placement.In (b)(6)2023, echography confirmed aortic insufficiency and and shortness of breath.In (b)(6) 2024, heart failure symptoms were confirmed, and the patient was aware of the heart failure.Aortic insufficiency was severe.On (b)(6) 2024, another aortic valve replacement procedure using a 19mm epic supra aortic valve was performed.The procedure was completed with no adverse patient effects.Upon explant, the was torn cusp (from the tip of the stent to nadir) of the valve.The patient is stable, and under observations.No medication was noted in this event.
Additional Manufacturer Narrative
Explant due to severe aortic insufficiency and shortness of breath after 5 years of valve implant was reported.Also reported that upon explant a torn cusp was noted on the valve.The investigation found cusps 2 and 3 were torn.There was patchy pannus formation on the outflow surface and on all cusps of inflow surface.Mild fibrous thickening was noted to cusps 1 and 2.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.The cause of the tear could not be conclusively determined; however, the fibrous pannus ingrowth noted on the cusps had the potential to induce increased stress on adjacent cusps and create an unbalanced stress relief distribution between all cusps during coaptation, leading to cusps tears and reduced durability.

• 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: 19529754
• Report Number: 2135147-2024-02766
• Device Sequence Number: 15373929
• 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: 2019
• Device Explanted Year: 2024
• 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): 08/21/2024

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: 06/25/2021
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6059555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2017
• 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 Age: 76 YR
• Patient Sex: Female