BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2195152 · Received July 14, 2011

    Report

    Report Number
    1649833-2011-00008
    Event Type
    Other
    Date Received
    July 14, 2011
    Date of Event
    July 1, 2009
    Report Date
    July 14, 2011
    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

    WE ONLY HAVE ACCESS TO THE PUBMED ABSTRACT. THE VALVE SERIAL NUMBER IS UNK, THUS DATE OF MFR, AND EXPIRY DATE ARE UNK. THE FULL JOURNAL ARTICLE COULD NOT BE LOCATED SO OTHER INFO SUCH AS DATE OF EVENT IS UNK. THE VALVE IS NOT AVAILABLE TO US FOR INVESTIGATION, AS IT WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    VALVE THROMBOSIS OF THE ON-X MITRAL VALVE PROSTHESIS. VALVE THROMBOSIS IS AN EXPECTED ADVERSE EVENT FOR A MECHANICAL HEART VALVE, AND IS PRE-DEFINED IN AATS/STS GUIDELINES AS "VALVE-RELATED." THEREFORE, IT IS BEING REPORTED. THIS CASE WAS REPORTED IN THE SAUDI MEDICAL JOURNAL, 2009 JUL;30(7):964-6. THIS WAS PICKED UP WHILE PREPARING THE PMA ANNUAL REPORT FOR PMA # P000037. ALL WE HAVE IS THE ABSTRACT, WHICH READS: "THROMBOSIS OF A MECHANICAL PROSTHETIC VALVE IS A SERIOUS AND FORTUNATELY IT IS A RARE COMPLICATION OF CARDIAC VALVE REPLACEMENT. WE PRESENT A CASE OF PROSTHETIC MECHANICAL VALVE (ONXM-31/33) THROMBOSIS, THROMBUS SIZE 8X14MM ON A MITRAL POSITION, WHICH WAS TREATED WITH A SUCCESSFUL INTRAVENOUS THROMBOLYTIC THERAPY OF STREPTOKINASE INFUSION OVER 10 HRS REPEATED TWICE WITH NO COMPLICATIONS." COULD NOT LOCATE THE FULL REPORT. THIS IS ALL THE INFO WE HAVE.

    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