BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 3052177 · Received April 9, 2013

    Report

    Report Number
    1649833-2013-00003
    Event Type
    Death
    Date Received
    April 9, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND PHOTO TAKEN. THE PHOTO WAS PROVIDED TO ONXLTI AND EVAL WAS BASED ON THAT PHOTO. THE VALVE IS NO LONGER AVAILABLE SO COULD NOT BE RETURNED FOR ANALYSIS BY ONXLTI. REVIEW OF DEVICE HISTORY RECORD SHOWS VALVE WAS BUILT PER SPECS. MITRAL VALVE THROMBOSIS IS AN EXPECTED EVENT AND OCCURS WELL-WITHIN THE EXPECTED RATE. THERE ARE NO TRENDS TOWARD INCREASING EVENTS.

    Description of Event or Problem · 1

    FROM DISCUSSIONS BETWEEN DISTRIBUTOR AND SURGEON, IT WAS LEARNED THAT A PT HAD A THROMBOSED ON-X MITRAL VALVE, 1 YEAR POST-OP. THE SURGEON PHOTOGRAPHED THE VALVE AFTER EXPLANT AND THE APPEARANCE OF THROMBUS COULD BE VERIFIED. NO ACTUAL COMPLAINT WAS EXPRESSED BY THE SURGEON. THE PT DIED OF A CEREBRAL BLEED, DUE TO COUMADIN TOO HIGH IN RESPONSE TO THROMBOSIS. NOTE: THE DATE OF DEATH IS APPROXIMATE BASED ON INFO FROM THE DISTRIBUTOR. EVENT OCCURRED IN (B)(6). VALVE THROMBOSIS IS BY DEFINITION VALVE-RELATED AND IS AN ADVERSE EVENT, PER ISO 5840 OBJECTIVE PERFORMANCE CRITERIA AND IN THE (B)(6) GUIDELINES. THEREFORE, IT IS REPORTABLE ON THE MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144821 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death