BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2560207 · Received May 8, 2010

    Report

    Report Number
    1649833-2010-00005
    Event Type
    Malfunction
    Date Received
    May 8, 2010
    Date of Event
    January 12, 2010
    Report Date
    April 30, 2010
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE IS BEING RETURNED. HAVE NOT YET HAD OPPORTUNITY TO INSPECT OR EVALUATE, THUS NO CONCLUSION YET. INVESTIGATION WILL BE DONE, AFTER WHICH A F/U REPORT MAY BE FILED.

    Description of Event or Problem · 1

    PT UNDERWENT MITRAL VALVE REPLACEMENT AND MODIFIED MAZE PROCEDURE. WHILE CLOSING STERNUM, HEART SUDDENLY WENT INTO VENTRICULAR FIBRILLATION, RIGHT VENTRICLE FILLED, WITH HIGH PRESSURE. NO ECHO DONE. THE SURGEON STATES IN OPERATIVE NOTES THAT IT WAS ASSUMED THAT THE VALVE MIGHT BE THE PROBLEM. THE VALVE WAS REMOVED AND LEAFLETS EXAMINED, THEIR MOVEMENT WAS THOUGHT TO BE WITH A LITTLE DIFFICULTY. PT WAS RE-OPERATED WITH ANOTHER ONXM-25 VALVE. THE PT RECOVERED AFTER THE NEW VALVE WAS IMPLANTED. NO OTHER DETAIL IS AVAILABLE AT THIS TIME.

    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 54 YR Required Intervention