BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 1996181 · Received February 18, 2011

    Report

    Report Number
    2029214-2011-00035
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 19, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT.OTHER LOT OF ONYX INVOLVED:MODEL# LOT# DOM EXPIRATION105-7100-080 8872984 7/14/2010 3/1/2013(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S AVM WAS TREATED WITH ONYX. AFTERWARD, THE PATIENT'S EXPERIENCED BODY DISORDER WITH CEREBELLUM INFARCTION. THE PHYSICIAN COMMENTS HE HAD EMBOLIZED NORMAL VESSEL NEAR THE AVM. AFTER ONE MONTH THE PATIENT IS RECOVERING FROM BODY DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-080 8081878

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability