BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-X CONFORM -X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 2326599 · Received October 7, 2011

    Report

    Report Number
    1649833-2011-00011
    Event Type
    Other
    Date Received
    October 7, 2011
    Report Date
    October 7, 2011
    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 HAS BEEN RETURNED, INVESTIGATION NOT YET COMPLETED. IN ALL PAST CASES OF CARBON PART BREAKAGE, THE INVESTIGATION CONCLUSION WAS "IATROGENIC", I.E., SOME SORT OF IMPROPER, ROUGH TREATMENT OF THE VALVE. THERE HAS BEEN NO STRUCTURAL DYSFUNCTION OR FAILURE OF THE ON-X PROSTHETIC HEART VALVE IN ITS HISTORY. SO, THE CONCLUSION OF THE INVESTIGATION IS EXPECTED TO BE SIMILAR TO THAT IN THE PAST.

    Description of Event or Problem · 1

    BROKEN VALVE. VALVE WAS NOT SEATING PROPERLY. SURGEON RE-INSERTED VALVE HOLDER, AND CLAMPED IT TOGETHER SO HE COULD PUSH THE VALVE BACK DOWN FURTHER. IN PROCESS OF DOING THIS, A PIECE OF CARBON BROKE OFF OF THE VALVE. NO EFFECT ON THE PT. THEY RETRIEVED THE PIECE. THIS SITUATION WAS REPORTED AS BEING CLEARLY IATROGENIC, NOT A FAULT OF THE VALVE. PT RECOVERED FROM THE SURGERY.

    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 Required Intervention