BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 2018947 · Received March 15, 2011

    Report

    Report Number
    2029214-2011-00056
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF AN AVM WITH ONYX. DURING PROCEDURE, IT WAS REPORTED THAT ONYX COULD NOT BE VISUALIZED UNDER THE FLUOROSCOPE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1