BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 1985146 · Received January 7, 2011

    Report

    Report Number
    1649833-2011-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE IS NOW IN-HOUSE, AWAITING INVESTIGATION. VISUAL INSPECTION WILL BE DONE, PHOTOGRAPHS, VERIFICATION OF LEAFLET FUNCTION IN AS-REC'D CONDITION, CLEANING, INSPECTION OF PROPER CUFF CONSTRUCTION, CUFF DISASSEMBLY, AND RETESTING OF THE LEAFLET BIND TEST, AND FUNCTIONAL INSPECTION.

    Description of Event or Problem · 1

    AFTER IMPLANT, ECHO TESTING REVEALED MOVEMENT OF ONE LEAFLET WAS RESTRICTED. SURGEON OPENED THE HEART FOR INVESTIGATION. HE TAPPED THE LEAFLET WITH A PROBE AND TRIED TO ROTATE THE VALVE BUT COULD NOT. THE SIZE 25 VALVE WAS REPLACED WITH A SMALLER VALVE, SIZE 23. PT'S POST-OP COURSE IS UNEVENTFUL THUS FAR. IT WAS STATED THAT THE EVENT MAY HAVE BEEN CAUSED BY OVERSIZING WHICH LEADS TO ANATOMICAL INTERFERENCE. THE RETURNED VALVE WAS JUST REC'D IN-HOUSE AND IS PENDING INVESTIGATION.

    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 UNK Required Intervention