BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2437006 · Received January 25, 2012

    Report

    Report Number
    2437006
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 25, 2012
    Manufacturer
    MEDTRONIC ATS MEDICAL, INC.
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S MITRAL VALVE APPEARED TO HAVE A QUITE MYXOMATOUS ANTERIOR LEAFLET. ON OUR TRANSESOPHAGEAL ECHOCARDIOGRAM, THE JET APPEARED TO BE DIRECTED POSTERIORLY. BECAUSE OF THIS, I DID NOT FEEL COMFORTABLE DOING REPAIR AND WENT AHEAD WITH REPLACEMENT AS WE HAD PLANNED. AFTER COMING OFF CARDIOPULMONARY BYPASS, THE PATIENT HAD SLUGGISH MOTION OF THE LEFT VENTRICLE WHICH WAS STEADILY IMPROVING. HOWEVER, FOR SAFETY, WE PLACED AN INTRAAORTIC BALLOON PUMP VIA THE LEFT FEMORAL ARTERY. WE FIRST PLACED A 31 MM PROSTHESIS INTO THE MITRAL ANULUS. HOWEVER, AFTER WE CAME OFF CARDIOPULMONARY BYPASS THE FIRST TIME, WE SAW THAT ONE OF THE LEAFLETS WAS NOT MOVING PROPERLY. WE WENT BACK ON PUMP TO INSPECT THIS. IT TURNED OUT THAT THE VALVE WAS PROBABLY A LITTLE BIT TOO BIG FOR THE PATIENT'S ANNULUS, AND THERE WAS NOT ROOM FOR ONE OF THE VALVE LEAFLETS TO OPEN AND CLOSE COMPLETELY. WE THEREFORE SWITCHED TO A 27 MM AND HAD EXCELLENT VALVE FUNCTION AFTER COMING OFF CARDIOPULMONARY BYPASS THE SECOND TIME, WITH NO EVIDENCE OF PERIVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CARDIOVASCULAR IMPLANT MITRAL VALVE LWR MEDTRONIC ATS MEDICAL, INC. 500DM31 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR