BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-X CONFORM -X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2326579 · Received October 7, 2011

    Report

    Report Number
    1649833-2011-00010
    Event Type
    Other
    Date Received
    October 7, 2011
    Date of Event
    September 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
    IN, US
    Reporter Occupation
    NURSE

    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

    LEAFLET BECAME DISLODGED DURING ATTEMPT TO ROTATE THE VALVE TO CLEAR INTERFERENCE FROM UNDERLYING PAPILLARY MUSCLES. PT RECOVERED FROM THE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention