BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS MEDICAL, INC.

    MDR report key: 670686 · Received February 2, 2006

    Report

    Report Number
    2134151-2006-00002
    Event Type
    Other
    Date Received
    February 2, 2006
    Date of Event
    January 5, 2006
    Report Date
    February 2, 2006
    Manufacturer
    ATS MEDICAL
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL AND REPLACEMENT OF HIS MITRAL VALVE SECONDARY TO MITRAL REGURGITATION. AFTER IMPLANTATION OF THE FIRST ATS MECHANICAL VALVE, UPON TYING THE SECOND OF THE LAST SUTURES TO HOLD IT IN PLACE, FORCEPS TOUCHED THE PYROLYTIC CARBON RING OF THE VALVE AND CHIPPED A VERY SMALL FRAGMENT (0.5MM X 1MM IN DIAMETER) OFF THE VALVE HOUSING. IT WAS BELIEVED THAT HIS IMPLANT SHOULD BE EXPLANTED. THE ATS COMPANY WAS CONTACTED AND THE ENGINEERS AGREED. THE VALVE WAS EXPLANTED. THE SECOND VALVE WAS IMPLANTED AND AFTER THE SUTURES WERE TIED AND BEING CUT, THE LEAFLET OF THE ATS VALVE FRACTURED AND DISLODGED. THIS VALVE REQUIRED EXPLANTATION AS WELL. A DIFFERENT CO MECHANICAL VALVE WAS THEN IMPLANTED SUCCESSFULLY. BOTH SURGICALLY REMOVED ATS VALVES WERE RETURNED TO ATS MEDICAL SALES PER THEIR REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS MEDICAL, INC. MECHANICAL HEART VALVE LWQ ATS MEDICAL 500DM31 2285

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention