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

Catalog Number	TFGT-23A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
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 23mm trifecta gt final package - wr was implanted in a patient.On (b)(6) 2024, the valve was explanted.It was reported that the valve was defective.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2019, a 23mm trifecta gt valve was implanted in a patient.On (b)(6) 2024, the valve was explanted.It was reported that the valve was defective.The patient status was unknown.
Additional Manufacturer Narrative
H6 health effect - impact code 4648 was removed.4624, 4607 added.An event of the defective valve and being explanted after 5 years of implant was reported.The investigation at abbott found that all three leaflets remained intact with limited mobility.Biological material was noted throughout the valve.The investigation found cusps 1 and 3 were torn.Fibrous thickening and contained coalesced calcifications which immobilized all cusps.The sewing cuff was excised in processing.There was circumferential pannus formation with narrowing of the inflow diameter to approximately 15 mm.There was no inflammation.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 torn cusps could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.In addition, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent cusps and create an unbalanced stress relief distribution between all cusps during coaptation, leading to cusp tear 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: 20463753
• Report Number: 2135147-2024-05107
• Device Sequence Number: 7765533
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)221021(10)6729449
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2024
• 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): 01/24/2025

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: 10/21/2022
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6729449
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2018
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female