BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1748158 · Received June 28, 2010

    Report

    Report Number
    2134151-2010-00005
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    April 20, 2010
    Report Date
    June 2, 2010
    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

    DEVICE HAS NOT YET BEEN RECEIVED BY ATS FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESSURES DID NOT COME TO APPROPIATE LEVEL AFTER IMPLANT OF THE ATS 16MM VALVE. THE DEVICE WAS THEN EXPLANTED AND THEN A BIGGER SIZE, 20MM, ATS VALVE WAS IMPLANTED. THERE WERE NO ADVERSE EVENTS AND THE PT IS DOING FINE. BOTH THE EXPLANT OF THE 16MM ATS VALVE AND THE IMPLANT OF THE 20MM ATS VALVE TOOK PLACE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS OPEN PIVOT BILEAFLET HEART VALVE ATS STANDARD AORTIC VALVE LWQ ATS MEDICAL, INC. 501DA16 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention