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

Catalog Number	TF-23A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); 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	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.It was reported that 525 patients underwent surgical aortic valve replacement, with 263 receiving an abbott trifecta or trifecta glide technology (gt) valve between january 2015 and december 2021.Three patients out of 263 were identified from the study period as having early svd requiring reintervention within three years of valve implantation.Five cases had cusp tears as their failure mechanism, raising concerns about durability.Some of the complications reported were aortic regurgitation, heart failure, surgical intervention, hospitalization, pannus, torn cusp.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device or individual patient information was received for analysis.
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 62-year-old female with congenital bicuspid aortic valve and history of hypertension.It was reported that on an unknown date, a 23mm trifecta valve was implanted in the patient.The patient presented 31 months later with acute severe aortic regurgitation and heart failure.A decision was made to explant the valve and replace with a 22mm non-abbott valve.It was found intraoperatively there was a torn non-coronary cusp of the trifecta valve.The explanted valve was examined and found to have pannus ingrowth on one leaflet.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: aortic regurgitation, heart failure, surgical intervention, hospitalization, pannus, torn cusp.*patient 1*.

• Brand Name: SJM TRIFECTA 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: 17684345
• Report Number: 2135147-2023-03854
• Device Sequence Number: 12350276
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• 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: TF-23A
• 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: 62 YR
• Patient Sex: Female