BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 1929815 · Received November 19, 2010

    Report

    Report Number
    1649833-2010-00010
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 16, 2010
    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

    COMMENTS FROM INVESTIGATION: CUFF WAS FOUND TO BE STUCK TO HOUSING BY WHAT APPEARED TO BE RESIDUES OF DRIED FLUIDS THE VALVE HAD BEEN IN CONTACT WITH (I.E., BLOOD, ET. AL.). AFTER 3 ATTEMPTS TO ROTATE, IT FREED UP AND ROTATED WITH A NOMINAL, IN-SPEC TORQUE WHICH COMPARED WELL WITH THE ORIGINAL DEVICE HISTORY RECORD. THE VALVE WAS SUBJECTED TO LEAFLET BIND TEST AND A DETAILED FUNCTIONAL INSPECTION, BOTH OF WHICH PASSED, INDICATING THE VALVE CONTINUES TO MEET SPEC.

    Description of Event or Problem · 1

    AFTER PATIENT TAKEN OFF OF PUMP, FOUND NO SYSTOLIC PRESSURE, THE VENTRICLE WAS FILLING AND EXPANDING. THE VALVE WAS NOT OPENING. THE LEAFLETS HAD BEEN TESTED OK AFTER SEATING THE VALVE. PATIENT PLACED BACK ON PUMP, TRIED TO ROTATE THE VALVE TO CLEAR POSSIBLE OBSTRUCTION, HOWEVER, THE VALVE WOULD NOT ROTATE. THE SURGEON DID NOT TEST THE VALVE'S OUT-OF-BOX ROTATABILITY AS INSTRUCTED IN THE IFU. THIS IS INTENDED TO DEMONSTRATE CAPABILITY TO ROTATE AND THE FEEL OF THE ROTATIONAL TORQUE. SURGEON STATED THERE WAS NO INDICATION OF ANATOMICAL INTERFERENCE. NO CALCIFICATION BLOCKING THE LEAFLETS. THE LEAFLETS APPEARED TO BE STUCK CLOSED. REPLACED THE ON-X VALVE WITH ANOTHER BRAND. PATIENT RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention