BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 4999233 · Received August 11, 2015

    Report

    Report Number
    1649833-2015-00021
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 8, 2015
    Report Date
    November 19, 2015
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001273
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    WAITING ON ARRIVAL OF VALVE. THEN INVESTIGATION WILL BE DONE. IT IS EXPECTED THAT, AS IN ALL PAST INVESTIGATIONS OF LEAFLET MOTION PROBLEMS, IT WILL BE SHOWN THAT THERE IS NO TROUBLE FOUND. THIS INITIAL MDR FILED BECAUSE THE 30-DAY LIMIT WILL TRANSPIRE BEFORE INVESTIGATION CONCLUSIONS ARE IN PLACE. A F/U MDR WILL BE PREPARED AT THAT TIME. REVIEW OF DEVICE HISTORY RECORDS FOR THIS VALVE SHOWS THE VALVE WAS BUILT PER SPECS.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). ON-X MITRAL VALVE WAS USED IN MITRAL VALVE REPLACEMENT CASE. ECHO CHECK AFTER SURGERY FOUND SEVERE MITRAL REGURGITATION. SURGEON THOUGHT IT MIGHT BE DUE TO MALFUNCTION OF THE VALVE LEAFLET, NOT PARAVALVULAR LEAK. THE VALVE WAS EXPLANTED AND REPLACED. DR. (B)(6) WANTED TO KNOW IF THERE IS ANY PROBLEM WITH THE EXPLANTED VALVE. THE VALVE IS BEING RETURNED TO ON-X FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524987 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM 00851788001273

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention