BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1669112 · Received April 16, 2010

    Report

    Report Number
    2134151-2010-00001
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 22, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE DISCARDED AT HOSPITAL. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE CONFIRMED THAT IT MET ALL SPECIFICATIONS AND PASSED ALL INSPECTIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    REPORTEDLY, ONE OF THE VALVE'S LEAFLETS WAS NOT MOVING WELL. VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE OF THE SAME TYPE AND SIZE. AT EXPLANT, DOCTOR REPORTED THAT NATIVE TISSUE WAS OBSTRUCTING THE VALVE OPENING AND CLOSING. NO PATIENT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT.

    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. 501DA20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention