BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 2085035 · Received May 11, 2011

    Report

    Report Number
    2029214-2011-00101
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 14, 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. (B)(4). LOT # AND MODEL# OF THE 10 ONYX INVOLVED: MODEL#: 105-7100-080; LOT#: 8990684; DOM: 07/21/2010; EXPIRATION: 04/01/2013. MODEL#: 105-7100-080; LOT#: 9387299; DOM: 012/13/2010; EXPIRATION: 11/01/2013. MODEL#: 105-7100-060; LOT#: 9394845; DOM: 01/6/2011; EXPIRATION: 12/01/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S AVM WAS TREATED WITH 10 VIALS OF ONYX. POST PROCEDURE, THE PATIENT EXPERIENCED CEREBELLAR INFARCTION, THROMBOCYTOPENIA, AND NEUROLOGICAL BECAME WORSE COMPARING WITH PRE-EMBOLIZATION. THE PHYSICIAN THINKS THE ADVERSE EVENT CAME FROM CEREBELLAR INFARCTION DUE TO FEEDER OCCLUSION. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS THE 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 62 YR Disability