BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS AORTIC TOP HAT MECHANICAL VALVE

    MDR report key: 1201603 · Received October 16, 2008

    Report

    Report Number
    3005687633-2008-00002
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    May 6, 2008
    Report Date
    July 15, 2008
    Manufacturer
    CARBOMEDICS, INC
    Product Code
    LWQ
    PMA / PMN Number
    P900060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE IS CURRENTLY UNDERWAY, BUT NOT YET COMPLETE. METHOD = A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. RESULTS = THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL AND PERFORMANCE REQUIREMENTS AT THE TIME OF MFR AND RELEASE.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED OF A SIZE 25 MM AORTIC TOP HAT VALVE EXPLANTED AFTER APPROX 6 YRS FOR THROMBOTIC OCCLUSION OF ONE LEAFLET OF THE DEVICE WITH PARTIAL IMPINGEMENT OF THE OTHER LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS AORTIC TOP HAT MECHANICAL VALVE PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC S500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention