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

Catalog Number	TFGT-23A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/01/2024
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) 2018, a 23mm trifecta gt final package - wr was implanted in a patient.Around on (b)(6) 2020, palpitations began to occur, and mild to moderate regurgitation was observed.After monitoring, the condition progressed due to severe regurgitation around on (b)(6) 2023.During a regular check-up on (b)(6) 2024, the laceration has extended from the left coronary cusp (lcc) to the right coronary cusp (rcc) stent post.A plan for re-operation was made and on device was explanted on (b)(6) 2024 due to a laceration.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2018, a 23mm trifecta gt valve was implanted during an aortic valve replacement.The native aortic valve annulus was measured to be 24mm.Around (b)(6) 2020, the patient began to experience palpations, and mild to moderate aortic regurgitation was observed.After monitoring, the condition progressed due to severe regurgitation around (b)(6) 2023.In (b)(6) 2024, the plan was made for reoperation.The patient was experiencing heart failure due to severe regurgitation and structural valve deterioration.On (b)(6) 2024, the valve was explanted and replaced with a 23mm non-abbott valve.A laceration on the explanted valve was noted, which extended from the left coronary cusp (lcc)/right coronary cusp (rcc) stent post to the lcc side.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of torn cusp, central regurgitation, and structural valve deterioration was reported.The device was returned to abbott for investigation and it was observed that one of the leaflets was torn.The sewing cuff was intact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information, the cause of the reported event could not be conclusively determined.Per case detail, heart failure due to severe regurgitation and structural valve deterioration.The reported hospitalization and surgical intervention were resulted of case-specific circumstances.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: 20558087
• Report Number: 2135147-2024-05373
• Device Sequence Number: 8996565
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)210614(10)6052533
• 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: 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): 01/27/2025

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: 06/14/2021
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6052533
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2017
• 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: 54 YR
• Patient Sex: Male