BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 3904401 · Received June 24, 2014

    Report

    Report Number
    3904401
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC HEART VALVES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    A MOSAIC MITRAL VALVE WAS OPENED. AS SURGEON WAS LOADING IT ONTO THE VALVE HOLDER, THE VALVE SEPARATED FROM THE BLUE CARRIER AND WE NOTICED THE SUTURE WAS BROKEN.WE OPENED AN IDENTICAL VALVE WHICH WAS IMPLANTED WITHOUT INCIDENT.THE REP WAS NOTIFIED, SO HE IS AWARE OF THE SITUATION. WE ARE WORKING ON GETTING A REPLACEMENT FOR OUR STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368938 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT LWR MEDTRONIC HEART VALVES 310 CINCH *

    Patients

    Seq Age Sex Outcome Treatment
    1 *