BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 2066384 · Received April 21, 2011

    Report

    Report Number
    2029214-2011-00086
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 25, 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. (B)(4).MODEL# AND LOT# OF OTHER ONYX INVOLVED:MODEL# LOT# DOM EXPIRATION105-7100-060 9383028 12/01/2010 10/01/2013105-7100-080 9204273 08/25/2010 05/01/2013105-7100-080 8805424 06/22/2010 03/01/2013

    Description of Event or Problem · 1

    TREATMENT OF A RIGHT CEREBRAL AVM. IT WAS REPORTED THAT THE PATIENT'S AVM WAS TREATED WITH ONYX AND NBCA GLUE. SAME DAY, THE AVM WAS RESECTED AND THE PATIENT EXPERIENCED ACUTE RENAL FAILURE. THE PHYSICIAN BELIEVES THAT THE PATIENT'S ACUTE RENAL FAILURE WAS DUE TO THE EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9373710

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention| S