BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 2090365 · Received May 16, 2011

    Report

    Report Number
    2029214-2011-00112
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 18, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT.(B)(4)

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF A SPINAL DURAL FISTULA WITH ONYX. IT WAS REPORTED WHILE REMOVING THE CATHETER AT THE END OF THE PROCEDURE, THE DISTAL SECTION BROKE OFF AND REMAINS IN THE PATIENT'S VESSEL. THE AMOUNT OF ONYX REFLUX WAS REPORTED TO BE 3CM.NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2011-00111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 9406916

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability