BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC SUPRA STENTED TISSUE VALVE

    MDR report key: 9461850 · Received December 12, 2019

    Report

    Report Number
    3001883144-2019-00127
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF OLIGURIA, EXERTIONAL DYSPNEA, ABDOMINAL DISTENSION, BILATERAL LEG EDEMA, ATRIAL FIBRILLATION, TRICUSPID STENOSIS, REGURGITATION, AND THE LEAFLETS BEING "THICKENED AND IMMOBILE" WAS REPORTED THROUGH A RESEARCH ARTICLE. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE REMAINS IMPLANTED WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    SHINSHU MED J. 67(5) : P289~292, 2019. TITLE: PERCUTANEOUS TRANSCATHETER BALLOON VALVULOPLASTY OF A STENOSED BIOPROSTHETIC TRICUSPID VALVE. CASE REPORT OF A (B)(6)-YEAR-OLD MAN WITH A HISTORY OF INFECTIOUS ENDOCARDITIS (IE) AND TWO PREVIOUS TRICUSPID VALVE REPLACEMENTS(TVRS). THE FIRST TVR AT AGE 25 WAS PERFORMED SECONDARY TO IE USING A STAR EDWARDS BALL VALVE. THE REPEAT TVR USING AN EPIC BIOPROSTHESIS VALVE WAS PERFORMED AT AGE 51 DUE TO SEVERE BALL VALVE STENOSIS. AFTER 3 YEARS IMPLANT DURATION, STENOSIS WAS OBSERVED FROM EPIC BIOPROSTHESIS VALVE AT TRICUSPID VALVE. REPEAT SURGICAL VALVE REPLACEMENT IS AN EXTREMELY HIGH-RISK PROCEDURE. SO PERCUTANEOUS TRANSCATHETER TRICUSPID BALLOON VALVULOPLASTY (PTTBV) IS CONSIDERED AS AN ACCEPTABLE TREATMENT OPTION FOR SYMPTOMATIC SEVERE TRICUSPID VALVE STENOSIS. THERE HAVE BEEN FEW REPORTS OF SUCCESSFUL PTTBV PERFORMED AFTER BIOPROSTHETIC TVR. BUT SUCCESSFUL TREATMENT WITH PTTBV FOR BIOPROSTHETIC TRICUSPID VALVE STENOSIS WAS ACHIEVED WITHOUT COMPLICATIONS IN THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255872 EPIC SUPRA STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) CVD0030

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR