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

Catalog Number	TFGT-19A
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	07/04/2023
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) 2017, a 19mm trifecta gt valve was implanted during an aortic valve replacement.In (b)(6) 2023, patient began experiencing symptoms of heart failure and was later admitted to the hospital.Severe aortic regurgitation and mild mitral regurgitation were observed.There was also a 50mm tumor seen on the ascending aorta.On (b)(6) 2023, a mitral valve replacement and aortic valve replacement were performed.The trifecta valve was explanted and replaced with a 21mm non-abbott valve, and a 30mm non-abbott valve was implanted in the mitral valve.A bypass of selective saphenous vein graft to right coronary artery (svg-rca) was also added due to risk of right coronary artery occlusion.On the explanted trifecta valve, it was noted that circumferentially on the outflow side, there was a cusp tear corresponding to the right coronary cusp.The native aortic valve was reported to be 23mm in diameter.The patient status was stable.
Additional Manufacturer Narrative
Explant due to symptoms of heart failure, severe aortic regurgitation and mild mitral regurgitation was reported.The investigation found that all leaflets were torn.Leaflet 2 had a fold/retraction.There was calcification noted on leaflet 1 associated with tear.No inflammation was present.The device history record was also 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 tears and fold causing incomplete coaptation could have contributed to the reported regurgitation.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: 17438866
• Report Number: 2135147-2023-03367
• Device Sequence Number: 11395789
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• 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: 2017
• 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): 09/22/2023

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: 11/15/2018
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5757040
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2016
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG