BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1439469 · Received August 10, 2009

    Report

    Report Number
    2134151-2009-00006
    Event Type
    Injury
    Date Received
    August 10, 2009
    Date of Event
    June 25, 2009
    Report Date
    June 26, 2009
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE NOT YET RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE VALVE COULD NOT BE REVIEWED, SINCE THE SERIAL NUMBER OF THE VALVE IS NOT YET KNOWN. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE VALVE HAS NOT YET BEEN RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    REPORTEDLY, THE DOCTOR IMPLANTED A SIZE 21MM ATS OPEN PIVOT BILEAFLET HEART VALVE. AFTER THE CARDIOLOGIST PERFORMED A TEE, HE REPORTED A VALVE DYSFUNCTION. ONE OF THE LEAFLETS DID NOT APPEAR TO BE WORKING PROPERLY. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER ATS OPEN PIVOT BILEAFLET HEART VALVE ONE SIZE SMALLER, 19MM. 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. 500FA21 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention