BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 1960221 · Received December 17, 2010

    Report

    Report Number
    1649833-2010-00012
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    December 17, 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

    VALVE WAS CLEANED AND ROTATIONAL TORQUE RE-TESTED, THE VALVE MEETS SPECIFICATION. IT IS KNOWN THAT THE SURGEON IN THIS CASE DID NOT FOLLOW THE IFU WHERE IT IS STATED THAT A OUT-OF-BOX TORQUE TEST IS TO BE PERFORMED SO THE SURGEON KNOWS THE VALVE WILL ROTATE IF THE NEED WERE TO ARISE, AND ALSO HOW THE RESISTANCE OF THE ROTATION FEELS. THIS ALLOWS HIM TO COMPARE WHEN ATTEMPTING ROTATION, AND IT WOULD TELL HIM THAT LACK OF ABILITY TO ROTATE IS NOT A VALVE ISSUE, IT IS SOME OTHER INTERFERENCE FACTOR. THE IFU ALSO EXPLICITLY STATES THAT THE VALVE IS TO BE REMOVED IF RESISTANCE TO ROTATION IS EXPERIENCED, AND IT IS ALSO CLEAR THAT, TO PREVENT BREAKAGE, NO OTHER INSTRUMENTS ARE TO BE USED TO GRAB THE VALVE. THE PRIMARY CAUSE FACTOR FOR THIS EVENT IS BEING DOCUMENTED IN OUR COMPLAINT SYSTEM AS "IATROGENIC", AND NOT AS A PRODUCT FAULT/MALFUNCTION.

    Description of Event or Problem · 1

    DURING ROUTINE INTERACTION WITH THE ON-X LIFE TECHNOLOGIES, INC TRACKING SYSTEM, IT WAS OBSERVED THAT THE IMPLANT CARD FOR A VALVE WAS MARKED AS "EXPLANTED". PRELIMINARY INVESTIGATION REVEALED THAT THE SURGEON WAS UNABLE TO LEAVE THE VALVE IN PLACE BECAUSE IT WOULD NOT ROTATE. HE FORCED IT WITH AN INSTRUMENT AND BROKE A PIECE OF THE VALVE HOUSING. (NOTE: HOSPITAL - (B)(6)).

    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 UNK Other