BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2099535 · Received May 13, 2011

    Report

    Report Number
    1649833-2011-00005
    Event Type
    Other
    Date Received
    May 13, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE JUST ARRIVED, TODAY'S DATE, INVESTIGATION HAS NOT YET STARTED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THE VALVE WAS BUILT PER SPECIFICATIONS. THE VALVE WILL BE SENT TO OUR SUPPLIER OF PATHOLOGICAL ANALYSIS SERVICE FOR CONFIRMATION OF THROMBUS. IN EVERY CASE OF PATHOLOGICAL ANALYSIS OF A THROMBOSED VALVE, THE PATHOLOGIST CONFIRMED THAT THE MATERIAL WAS THROMBUS. AT THIS TIME, WE DO NOT EXPECT TO LEARN ANYTHING IN ADDITION TO THE CONFIRMATION OF THROMBUS. THUS, A FOLLOW-UP REPORT IS NOT EXPECTED TO BE NECESSARY.

    Description of Event or Problem · 1

    DYSFUNCTION OF MITRAL VALVE PROSTHESIS DUE TO THROMBUS IN SPITE OF ADEQUATE ANTICOAGULATION THERAPY. PER STS/AATS GUIDELINES, THIS IS BY DEFINITION VALVE-RELATED AND IS THEREFORE BEING REPORTED. VALVE THROMBOSIS IS AN EXPECTED ADVERSE EVENT AND THIS OCCURRENCE IS WELL WITHIN EXPECTED RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention