BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 27/29MM

    MDR report key: 5995294 · Received October 3, 2016

    Report

    Report Number
    1649833-2016-00021
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    UDI-DI
    00851788001280
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO INFORMATION IS AVAILABLE REGARDING THE REASON FOR VALVE EXPLANT. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND INSTRUCTION FOR USE (IFU). THE IFU STATES IT IS POSSIBLE THAT COMPLICATIONS OF PROSTHETIC HEART VALVES COULD LEAD TO REOPERATION OR EXPLANTATION.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT RECEIVED ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 27/29MM IN 2010. THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS IN (B)(6) 2014 AND THE PATIENT RECEIVED ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING - 25/33MM. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING THE REASON FOR REOPERATION, OPERATIVE NOTES, AND PATIENT COMORBIDITES; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645609 ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 27/29MM MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXM-27/29 00851788001280

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention