BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2875742 · Received December 13, 2012

    Report

    Report Number
    1649833-2012-00015
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE IS IN QUEUE FOR INVESTIGATION, TO BE COMPLETED BY FIRST HALF OF (B)(6). AT THAT TIME, IT IS EXPECTED THAT A FOLLOW-UP REPORT WILL BE SENT WITH THE CONCLUSIONS OF THE INVESTIGATION. PRIOR OCCURRENCE OF THIS TYPE OF FIELD REPORT IS 16 TOTAL IN HISTORY OF THE DEVICE, OR ABOUT 119 PPM RECURRENCE RATE. IN 11 OF THE 16, THE PRODUCT WAS ABLE TO BE RETURNED AND INVESTIGATED AND ALL WERE FOUND TO BE IN CONFORMANCE WITH SPECS. THERE HAS NOT BEEN A CONFIRMATION OF MALFUNCTION THUS FAR. THE MAIN ISSUE IS SOME SORT OF MECHANICAL INTERFERENCE. IN THE MITRAL POSITION, IT IS USUALLY INTERFERENCE WITH RETAINED MITRAL APPARATUS. THE SURGEON HAS INDICATED THAT THE PATIENT HAD PHYSIOLOGICAL ISSUES, WHICH SUGGEST INTERFERENCE WITH THE VALVE FUNCTION.

    Description of Event or Problem · 1

    SURGEON STATES LEAFLETS NOT WORKING PROPERLY. PATIENT HAD HIGHLY CALCIFIED ANNULUS (MITRAL VALVE). SURGEON STATED HE WAS NOT BLAMING THE ON-X VALVE. JUST WANTED ONXLTI TO EXAMINE IT AND PROVIDE COMMENTS. THE PATIENT HAD PHYSIOLOGIC ISSUES (RELATIVE TO INTERFERENCE WITH VALVE). THE EVENT IS BEING REPORTED ONLY BECAUSE THE INVESTIGATION IS NOT YET COMPLETE. EVENT OCCURRED INTRA-OPERATIVE. (EVENT OCCURRED AT (B)(6)).

    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