BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1748159 · Received June 28, 2010

    Report

    Report Number
    2134151-2010-00004
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT YET BEEN RECEIVED BY ATS FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR PERFORMED A DOUBLE VALVE REPLACEMENT SURGERY USING TWO ATS VALVES. WITHIN FOUR HOURS OF SURGERY, THE MITRAL VALVE GOT "STUCK" AND THE PT HAD TO UNDERGO A RE-OPERATION. THE ATS VALVE WAS EXPLANTED AND A 27MM SJM VALVE WAS IMPLANTED. NO PT PROBLEMS WERE REPORTED AS THE 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. 500DM27 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention