BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1351835 · Received March 23, 2009

    Report

    Report Number
    2134151-2009-00002
    Event Type
    Other
    Date Received
    March 23, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 19, 2009
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED VALVE IS CURRENTLY BEING EVALUATED. THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED. THE VALVE WAS BUILT TO SPECIFICATIONS, AND PASSED ALL TESTS AND INSPECTIONS PRIOR TO RELEASE. A ROOT CAUSE HAS NOT YET BEEN DETERMINED BECAUSE THE INVESTIGATION IS NOT YET COMPLETE. VALVE HAS BEEN RETURNED, BUT THE INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    REPORTEDLY, ONE OF THE LEAFLETS FELL OFF DURING IMPLANT PROCEDURE; LEAFLET FELL INTO LEFT VENTRICLE AND HAD TO BE RETRIEVED BY THE SURGEON. NO PATENT ISSUES WERE REPORTED AS A RESULT OF THIS EVENT. ANOTHER VALVE WAS USED IN ITS PLACE SUCCESSFULLY.

    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. 500FA25 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention