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

Catalog Number	TFGT-21A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Valvular Insufficiency/ Regurgitation (4449)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature article: case series of early structural valve deterioration of trifecta bioprosthesis - new zealand experience.As reported in a research article, an event of severe valvular regurgitation due to a cusp tear was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Using the device in a position not recommended in the instructions for use could have contributed to the reported event.
Event or Problem Description
The article, "case series of early structural valve deterioration of trifecta bioprosthesis - new zealand experience", was reviewed.The article presented a case study of an 87-year-old female with significant history of paroxysmal atrial fibrillation on warfarin and mild renal impairment.It was reported that on an unknown date, a 21mm trifecta valve was implanted in the patient with a concomitant coronary aortic bypass graft procedure.The patient presented 17 months later with moderate to severe valvular regurgitation due to a cusp tear confirmed via transesophageal echocardiography (tee).A decision was made to explant the valve and replace with a 23mm non-abbott valve.The article concluded the trifecta valve has an acceptable safety profile and offers good hemodynamics due to the externally mounted leaflets.However, their experience of early svd and failure is concerning for valve durability.Further comparison to other bioprosthetic valves and longer term follow-up are required to characterize the mechanism of failures.[(b)(6)].Post-procedural complications included: valvular regurgitation, surgical intervention, hospitalization, torn cusp *patient 2*.

• 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: 17684934
• Report Number: 2135147-2023-03859
• Device Sequence Number: 6179732
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TFGT-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 87 YR
• Patient Sex: Female