BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1326835 · Received February 20, 2009

    Report

    Report Number
    2134151-2009-00001
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 6, 2009
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE NOT YET RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED. THE VALVE WAS BUILT TO SPECIFICATIONS, AND PASSED ALL TESTS AND INSPECTIONS. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE VALVE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. BASED ON THE DOCTOR'S REPORT, IT APPEARS AS IF SUBVALVAR TISSUE MAY HAVE BEEN IMPINGING UPON THE HINGE MECHANISM. VALVE NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT UPON SEPARATION FROM BYPASS, THE TEE SHOWED SEVERE PROSTHETIC MITRAL REGURGITATION. ONE LEAFLET APPEARED TO BE "FROZEN" OPEN. PT WAS PUT BACK ON BYPASS AND VALVE WAS REPLACED WITH TISSUE BIOPROSTHESIS. PHYSICIAN NOTED THAT SUBVALVAR TISSUE MAY HAVE BEEN IMPINGING UPON THE HINGE MECHANISM. NO PT ISSUES 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. 500DM27

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ATS STANDARD MITRAL VALVE: MODEL 500DM27| ROTATOR AND HEX HEAD INSTRUMENT: MODEL 568