BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 1927748 · Received November 19, 2010

    Report

    Report Number
    1649833-2010-00009
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    August 25, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING ROUTINE INTERACTION WITH THE ON-X LIFE TECHNOLOGIES, INC TRACKING SYSTEM, IT WAS OBSERVED THAT A NEW IMPLANT CARD FOR A MITRAL VALVE WAS RECEIVED FOR A PT WHO ALREADY HAD AN ON-X MITRAL VALVE PROSTHESIS. THE SURGEON WAS CONTACTED AND REQUESTED TO EXPLAIN WHY THIS HAPPENED, AND HE STATED: PT REQUIRED A DE-DO MITRAL VALVE REPLACEMENT BECAUSE, THE FIRST VALVE PROSTHESIS THROMBOSED (B)(4) DUE TO INADEQUATE, SUBTHERAPEUTIC ANTI THROMBIN THERAPY. "GIVEN THAT HER INITIAL POST-OP COURSE WAS MARKED BY ANTI-COAGULATION MEDICATION UNDER-TREATMENT, IT IS MY JUDGEMENT THAT THE VALVE SHOULD NOT BE CONSIDER 'AT-FAULT'. ANOTHER ON-X VALVE WAS IMPLANTED AND SHE IS FARING WELL, DISCHARGED FROM HOSPITAL. THE EXPLANTED VALVE WAS SUBMITTED TO SURGICAL PATHOLOGY DEPT. AT THE HOSPITAL." ONXLTI IS NOT ABLE TO GET THE RESULTS OF THE PATHOLOGY OR RETURN OF THE VALVE.

    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