BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1705652 · Received May 28, 2010

    Report

    Report Number
    2025587-2010-00048
    Event Type
    Death
    Date Received
    May 28, 2010
    Report Date
    May 4, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - DEVICE HISTORY WAS NOT REVIEWED AS NO SERIAL NUMBER WAS PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE REACHED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE PT IMPLANTED WITH THIS BIOPROSTHETIC VALVE DIED. IT WAS REPORTED THAT THE STENT POST OF THE VALVE WORE A HOLE THROUGH THE PT'S VENTRICULAR WALL. NOTE: PAPER COPY MEDWATCH 2953200201000924 WAS MISTAKINGLY SENT REGARDING THIS SAME PT (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC 310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death