BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X CONFORM-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2230637 · Received August 12, 2011

    Report

    Report Number
    1649833-2011-00009
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    August 5, 2010
    Report Date
    August 12, 2011
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INVESTIGATING ANOTHER EXPLANT FROM THIS SAME PT, (REPORTED IN MDR # (B)(4)), IT WAS REALIZED THAT A PRIOR ON-X MITRAL VALVE PROSTHESIS HAD THROMBOSED AND IT HAD NOT BEEN REPORTED TO US. THIS PROMPTED US TO REPORT THIS EXPLANT. THE EXPLANTED VALVE HAD BEEN DISCARDED SO IT IS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, IN EVERY CASE OF PATHOLOGICAL ANALYSIS OF A THROMBOSED VALVE FROM (B)(6), THE PATHOLOGIST CONFIRMED THAT THE MATERIAL WAS THROMBUS. THERE WILL BE NO F/U REPORT FOR THIS MDR. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE SHOWED THAT THE VALVE WAS BUILT PER SPECIFICATIONS.

    Description of Event or Problem · 1

    VALVE THROMBOSIS OF THE ON-X MITRAL VALVE PROSTHESIS. VALVE THROMBOSIS IS AN EXPECTED ADVERSE EVENT FOR A MECHANICAL HEART VALVE, AND IS PRE-DEFINED IN AATS/STS GUIDELINES AS "VALVE-RELATED". THEREFORE IT IS BEING REPORTED. COMMENTS FROM SURGEON'S OPERATIVE NOTES: THIS IS A RE-DO MITRAL VALVE REPLACEMENT (MVR). ONXMC-25/33 VALVE LEAFLET STUCK WITH CLOT. VALVE WAS EXPLANTED AND REPLACED. THERE IS NO RECORD OF THE PT'S COMPLIANCE WITH ANTICOAGULATION THERAPY. PT RECOVERED FROM THE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention