BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1253345 · Received December 2, 2008

    Report

    Report Number
    2134151-2008-00004
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MODEL OR SERIAL NUMBER OF THE VALVE WAS PROVIDED. THE VALVE IS NOT EXPECTED TO BE RETURNED, THEREFORE, NO DEVICE EVALUATION WAS POSSIBLE.

    Description of Event or Problem · 1

    UNCONFIRMED REPORT OF LEAFLET ESCAPE APPROXIMATELY TWELVE MONTHS POST IMPLANT. IT WAS REPORTED THAT AN AORTIC VALVE WAS EXPLANTED AND ANOTHER ATS AORTIC VALVE WAS IMPLANTED. PHYSICIAN REPORTS NO INJURY. THE VALVE IS NOT BEING RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION AND ECHOCARDIOGRAPHIC VIDEO HAS BEEN REQUESTED, BUT NOT RECEIVED. NO MODEL OR SERIAL NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS OPEN PIVOT BILEAFLET HEART VALVE HEART VALVE MECHANICAL LWQ ATS MEDICAL, INC. NOT KNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention