BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5852059 · Received August 5, 2016

    Report

    Report Number
    2029214-2016-00659
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    March 5, 2015
    Report Date
    July 8, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHUANHUI LI ; YANG WANG; YOUXIANG LI, ET AL. CRANIAL NERVE DYSFUNCTION ASSOCIATED WITH CAVERNOUS DURAL ARTERIOVENOUS FISTULAS AFTER TRANSVENOUS EMBOLIZATION WITH ONYX. CARDIOVASC INTERVENT RADIOL (2015) 38:1162¿1170 DOI 10.1007/S00270-015-1062-Y THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH REVIEW OF LITERATURE THAT ONE PATIENT EXPERIENCED DELAYED RIGHT CN VI PALSY 3 MONTHS POST TRANSVENOUS EMBOLIZATION TREATMENT. THE CN VI PALSY IMPROVED SIGNIFICANTLY, BUT WAS NOT COMPLETELY RESOLVED DURING LATER CLINICAL FOLLOW UP. THE PATIENT WAS TREATED WITH BOTH ONYX AND COILS AND HAD COMPLETE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503098 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability