BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1218008 · Received October 30, 2008

    Report

    Report Number
    2134151-2008-00003
    Event Type
    Death
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P440046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND FOUND TO BE WITHIN SPECIFICATIONS AND MET ALL ACCEPTANCE CRITERIA. PT'S CONDITION- PREDISPOSED EVENT. THE PT HAD HAD RHEUMATIC FEVER AND THE ANNULUS WAS VERY CALCIFIED. DEVICE NOT RETURNED- NO EVALUATION. NO VALVE IS BEING RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE TRIPLE VALVE PROCEDURE STARTED WITH THE MITRAL VALVE REPLACEMENT; THE SURGEON IMPLANTED AN AP MITRAL, 28MM. AN AP AORTIC VALVE WAS IMPLANTED AND A TRICUSPID REPAIR WAS PERFORMED. UNDER ECHOCARDIOGRAPHIC VISUALIZATION IT WAS APPARENT THAT THERE WAS A LOT OF PERIVALVULAR LEAKING AROUND THE MITRAL VALVE. THE SURGEON WENT IN TO RESOLVE THE LEAK, AT WHICH TIME AN LV SEPARATION OR TEAR WAS NOTED. THE 28MM AP MITRAL WAS EXPLANTED, AND A 25MM VALVE ALONG WITH A PATCH WAS IMPLANTED. THEY WERE NOT ABLE TO STOP THE BLEEDING AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS OPEN PIVOT BILEAFLET HEART VALVE HEART VALVE MECHANICAL LWQ ATS MEDICAL, INC. 501DM28 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death