BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 16781617 · Received April 20, 2023

    Report

    Report Number
    2135147-2023-01745
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    November 6, 2020
    Report Date
    April 20, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05414734052047
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, A VEGETATION AND ENDOCARDITIS WAS FOUND ON A VALVE THAT HAD BEEN IMPLANTED FOR FIVE YEARS. A MORE COMPREHENSIVE ASSESSMENT, INCLUDING HISTOPATHOLOGICAL EXAMINATION OF THE VALVE TISSUE COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ABSTRACT ARTICLE, "TRIFECTA BIOPROSTHESES: EVALUATION OF THE SAFETY BASED ON THE STUDY OF DEGENERATIONS ACCORDING TO THE VARC-3 CLASSIFICATION", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE INTRINSIC IMPUTABILITY OF TRIFECTA FOR DYSFUNCTION ACCORDING TO THE VARC-3 CLASSIFICATION IN PATIENTS IMPLANTED AND TO REASSESS THEIR REFERENCING IN OUR CENTER. TRIFECTA VALVE WAS THE DEVICE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED, THE CLASSIFICATION OF FAILURES ACCORDING TO VARC-3 INDICATED THE INTRINSIC IMPUTABILITY OF THE TRIFECTA¿ BIOPROSTHESES REGARDING TO THE NUMBER OF SVD-TYPE DYSFUNCTIONS. ALTHOUGH THIS STUDY HAS LIMITATIONS, IT SHOWS THE UNDERSTATEMENT OF MEDICAL-DEVICES-VIGILANCE CASES BY THE MEDICAL STAFF. [THE PRIMARY AUTHOR OF THIS ARTICLE IS RICHEZ, OPHELIE, AMIENS-PICARDIE UNIVERSITY HOSPITAL, 1 ROND-POINT DU PROFESSEUR CHRISTIAN CABROL, 80054 AMIENS, FRANCE, WITH EMAIL ADDRESS OF : [email protected]]. IT WAS REPORTED THAT IN (B)(6) 2013, A 25MM TRIFECTA VALVE WAS IMPLANTED IN A PATIENT WITH A PAST MEDICAL HISTORY OF AORTIC INSUFFICIENCY. IT WAS REPORTED THAT IN (B)(6) 2018, THE PATIENT HAD MITRO-AORTIC ENDOCARDITIS, ECCENTRIC RECEDING BIOPROSTHESIS PLUNGING TOWARDS THE LARGE MITRAL VALVE. THE WAS ALSO LOWER RIGHT SIGMOID THICKENING WHICH REMAINS MOBILE, VEGETATION > 10MM. NO ABSCESS OR PARAPROSTHETIC LEAK. 7MM VIBRATE IMAGE ON THE AURICULAR SIDE OF THE SMALL MITRAL VALVE WITH IM GRADE 1. ABSENCE OF DAMAGE TO THE OTHER VALVES. ON (B)(6) 2018, A SURGICAL INTERVENTION WAS COMPLETED WITH A NEW TRIFECTA 25MM VALVE. POST PROCEDURE OF THE SECOND VALVE IN (B)(6) 2020, THERE WAS DILATION OF THE ASCENDING AORTA MEASURED AT 4 CM GREATER, POLY-VALVULAR HEART DISEASE WITH A SIGNIFICANT MITRAL LEAK AND SEVERE AORTIC INSUFFICIENCY AND AC / AF. REQUIRING REPLACEMENT WITH A 21MMREGENT HEART VALVE W/FLEX CUFF. PATIENT STATUS IS UNKNOWN, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155952 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL TF-A 05414734052047

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention