BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 4851022 · Received June 17, 2015

    Report

    Report Number
    2029214-2015-00707
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    January 19, 2015
    Report Date
    May 18, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007/S00062-015-0374-2. THE ONYX WAS NOT RETURNED FOR EVALUATION, THEREFORE THE EVENT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. NOTE: AS PER THE IFU PRINCIPAL OF OPERATION INDICATES: THE ONYX LES DELIVERED BY SLOW CONTROLLED INJECTION THROUGH A MICRO CATHETER. (B)(4). INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFRS: 2029214-2015-00705.

    Description of Event or Problem · 1

    CITATION: J. LUTZ, ET AL. PREOPERATIVE EMBOLIZATION TO IMPROVE THE SURGICAL MANAGEMENT AND OUTCOME OF JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA) IN A SINGLE CENTER: 10-YEAR EXPERIENCE. CLIN NEURORADIOL DOI 10.1007/S00062-015-0374-2. THE FOLLOWING REPORT WAS RECEIVED THROUGH REVIEW OF LITERATURE: ONE PATIENT HAD A TRANSIENT HEMIPARESIS OF THE LEFT ARM FOR A FEW MINUTES AFTER THE ONYX EMBOLIZATION, AS A RESULT OF A TINY DISPERSE ONYX IN THE MIDDLE CEREBRAL ARTERY (MCA) TERRITORY, PRESUMABLY DUE TO A VIDIAN ARTERY COLLATERAL. THE PATIENT HAD NO FURTHER NEUROLOGICAL PROBLEMS BEFORE OR AFTER THE SURGERY. FOR EXPLANATION, THIS WAS THE FIRST PATIENT TREATED WITH THE DIRECT PUNCTURE TECHNIQUE, WITHOUT A BALLOON PROTECTION. A TOTAL OF 15 PATIENTS WERE INCLUDED IN THIS SERIES ALL WERE MALE PATIENTS AGED BETWEEN 11 AND 36 YEARS (MEAN AGE, 15 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393691 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR