BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 2864371 · Received December 6, 2012

    Report

    Report Number
    1649833-2012-00014
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE SHOWED THAT THE VALVE WAS BUILT PER SPECIFICATIONS. NO FURTHER INFORMATION AVAILABLE, THUS NOT EXPECTING TO DO A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    VALVE THROMBOSIS OF THE ON-X MITRAL VALVE PROSTHESIS, POST-OPERATIVE (LATE). VALVE THROMBOSIS IS AN EXPECTED ADVERSE EVENT FOR A MECHANICAL HEART VALVE, AND IS PRE-DEFINED IN AATS/STS GUIDELINES AS "VALVE-RELATE". THEREFORE IT IS BEING REPORTED. COMMENTS FROM SURGEON'S OPERATIVE NOTES: ON-X "VALVE HAD HEALED IN WELL". ONXM-25 VALVE WAS EXPLANTED AND REPLACED WITH SORIN. PATIENT 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 15 YR Required Intervention