BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 2006567 · Received March 3, 2011

    Report

    Report Number
    2029214-2011-00043
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 4, 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 THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. MODEL# AND LOT# OF THE ONYX INVOLVED:MODEL# LOT# DOM EXPIRATION105-7100-080 8164455 2/11/2010 12/1/2012105-7100-060 8990685 7/21/2010 4/1/2013105-7100-060 8811866 6/29/2010 3/1/2013(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE AVM WAS TREATED WITH ONYX AND RESECTED ON THE SAME DAY. SUBSEQUENTLY, INTRACRANIAL HEMORRHAGE OCCURRED AND THE PATIENT EXPERIENCED PARALYSIS SYMPTOM ON LEFT BODY. THE PATIENT IS RECOVERING AT REHABILITATION. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability