BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM

    MDR report key: 6063470 · Received October 28, 2016

    Report

    Report Number
    3001883144-2016-00068
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA.
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE 27 MM SJM EPIC MITRAL VALVE WAS IMPLANTED SECONDARY TO SEVERE MITRAL REGURGITATION IN THE PRESENCE OF ACUTE LEFT HEART FAILURE. DURING THE MITRAL VALVE IMPLANT PROCEDURE, THE PATIENT'S LEFT VENTRICLE WAS PERFORATED AND SUTURE REPAIR WAS REQUIRED. ONE WEEK POSTOPERATIVELY, THE PATIENT'S CONDITION DETERIORATED AND THE PATIENT DIED ON (B)(6) 2016 REPORTEDLY DUE TO LEFT VENTRICULAR RUPTURE. THE VALVE REMAINED IMPLANTED. THE SURGEON REPORTS THE LEFT VENTRICULAR RUPTURE MAY HAVE BEEN BROUGHT ON BY THE USE OF SUTURE OR SOME OTHER MEDICAL INSTRUMENTS; HOWEVER, THE EXACT CAUSE REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716691 EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA. E100-27M BR00005586

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R