BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1729708 · Received June 14, 2010

    Report

    Report Number
    2134151-2010-00003
    Event Type
    Other
    Date Received
    June 14, 2010
    Date of Event
    April 8, 2010
    Report Date
    May 17, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CURRENTLY BEING EVALUATED BY ATS.

    Description of Event or Problem · 1

    REPORTEDLY, THE VALVE WAS IMPLANTED ON (B)(6) 2010. ON THE FIFTH DAY POST OPERATIVELY, THE PT'S LDH WENT UP TO 1800. REGURGITATION (WHICH WAS SUSPECTED AS TRANSVALVULAR LEAK) WAS DETECTED AND TISSUE INTERFERENCE WAS THOUGHT TO BE THE CAUSE. A REOPERATION WAS PERFORMED ON (B)(6) 2010, IMPLANTING A NEW MITRAL 16MM ATS VALVE. AT THE TIME OF THE REOPERATION, EXCESS TISSUE WAS ALSO TRIMMED FROM THE PT. AFTER THIS REOPERATION, STILL SOME TVR COULD BE SEEN BUT AN INCREASE IN LDH WAS NOT SEEN AND THE PT IS FINE. THREE DAYS POST SURGERY, TEE DEMONSTRATED THAT THE REGURGITATION WAS COMPLETELY GONE. NO PT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS OPEN PIVOT BILEAFLET HEART VALVE ATS STANDARD MITRAL VALVE LWQ ATS MEDICAL, INC. 500DM16 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention