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

Catalog Number	TF-21A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
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
The abstract "experience with valve in valve for externally wrapped bioprosthetic valve dysfunction" was reviewed.The article presented a case study of a 75-year-old male who underwent aortic valve replacement (avr) 7 years ago, using a 21mm trifecta valve.It was reported that the patient was re-admitted due to severe aortic regurgitation.Avr surgery was recommended, but re-operation was refused.A transcatheter aortic valve implantation (tavi) procedure was performed, using a non-abbott device via transfemoral approach.Trifecta was sewn diagonally to the aortic annulus, making it difficult to implant the tavi valve coaxially.Finally, tavi was successful due to acceptable para-valvular leak, and the patient was discharged on post-operative day 5.No additional information was provided.[the primary author was hiroshi onoda, toyama university hospital, toyama, japan].
Additional Manufacturer Narrative
As reported in a research article, report for clinical experience of valve in valve for the deterioration of the prosthetic valve which the leaflet is being externally mounted on the stent post.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.
Event or Problem Description
N/a.

• 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: 18185292
• Report Number: 2135147-2023-05127
• Device Sequence Number: 20494785
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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 Catalogue Number: TF-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: 10/31/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male