BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1407772 · Received June 25, 2009

    Report

    Report Number
    2134151-2009-00005
    Event Type
    Injury
    Date Received
    June 25, 2009
    Report Date
    April 27, 2009
    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

    VALVE NOT YET RETURNED FOR EVAL. THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED. THE VALVE WAS BUILT TO SPECIFICATIONS, AND PASSED ALL TESTS AND INSPECTIONS. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE VALVE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. VALVE NOT YET RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REPORTEDLY, PT RETURNED TO HOSP ONE YR AFTER VALVE IMPLANT BECAUSE OF A "STUCK VALVE". SURGEON "THROMBOLYSIS" THE VALVE AND IT OPENED. PT RETURNED AFTER TWO YRS AND WAS ADMITTED TO THE HOSP FOR THE SAME REASON. SURGEON WAS NOT ABLE TO "THROMBOLYSIS" THE VALVE SO HE REPLACED IT WITH ANOTHER VALVE. NO PT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER DETAILS AVAILABLE AT THE TIME OF THIS REPORT.

    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. 500DM29 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention