BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2406054 · Received January 4, 2012

    Report

    Report Number
    1649833-2012-00001
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    November 25, 2011
    Report Date
    January 4, 2012
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P00037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE IS NOT AVAILABLE FOR RETURN TO MFR, THEREFORE, A COMPLETE INVESTIGATION IS NOT POSSIBLE. IF THE VALVE BECOMES AVAILABLE FOR INVESTIGATION, THE PRELIMINARY INVESTIGATION PLAN INCLUDES PATHOLOGY ANALYSIS, AND RE-TESTING PER FUNCTIONAL SPECS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE SHOWED THAT THE VALVE WAS BUILT PER SPECS.

    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. VALVE THROMBOSIS IN A 10KG PEDIATRIC PT. BOTH LEAFLETS STUCK CLOSED, WITH THROMBUS FOUND ON BOTH ATRIAL AND VENTRICLE SIDES. SURGEON ATTRIBUTES THIS TO ANTICOAGULATION THERAPY WHERE PT-INRS WERE 1.10 ON (B)(6) 2011, 2.48 ON (B)(6) 2011, AND 6.99 ON (B)(6) 2011. ONXM-23 VALVE WAS EXPLANTED AND REPLACED. PT RECOVERED FROM THE SURGERY.

    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