BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1253344 · Received December 2, 2008

    Report

    Report Number
    2134151-2008-00006
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED IN A GLASS CONTAINER FILLED WITH A FORMALINE. THERE WAS NO EVIDENCE OF THROMBUS ON ANY INITIAL VISUAL INVESTIGATION, THE ORIFICE WAS FOUND TO HAVE A CHIP, MOST LIKELY DUE TO THE EXPLANT PROCEDURE. THE VALVE HAD NORMAL TISSUE GROWTH SURROUNDING IT. THE LEAFLETS FUNCTIONED ACCEPTABLY. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE WITHIN SPECIFICATION AND PASSED ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 22MM AORTIC VALVE WHICH WAS IMPLANTED TWO YEARS AGO WAS EXPLANTED, DUE TO THROMBOSED LEAFLET. THE VALVE WAS REPLACED WITH A TISSUE VALVE. THE REPORT STATES THE PATIENT WAS ON AN INCORRECT INR REGIMENT WHICH CAUSED THE THROMBOSIS. THE PATIENT'S ANTICOAGULANT REGIME IS NOW 8MG. THE PHYSICIAN DOES NOT ATTRIBUTE THE ATS VALVE FOR THE THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS OPEN PIVOT BILEAFLET HEART VALVE HEART VALVE MECHANICAL LWQ ATS MEDICAL, INC. 503DA22 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention