BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 1870954 · Received October 8, 2010

    Report

    Report Number
    2029214-2010-00219
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 10, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. ADDITIONAL MODEL AND LOT# OF THE ONYX INVOLVED; MODEL# 105-7000-060, 105-7000-080. LOT# 8387102, 8081878. DOM 04/2010, 06/2010. EXPIRATION 2/2013, 11/2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN EMBOLIZED 5 FEEDERS OF AN AVM. DURING EMBOLIZATION OF THE LAST FEEDER, THE PHYSICIAN NOTED BLEEDING AROUND THE AVM. THE PHYSICIAN COMMENTED THAT THE RAPID CHANGE OF BLOOD FLOW RAISED VENOUS PRESSURE IN THE AVM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 8133199

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention