BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX AVM

    MDR report key: 2034779 · Received March 31, 2011

    Report

    Report Number
    2029214-2011-00069
    Event Type
    Death
    Date Received
    March 31, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 1, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. MODEL# AND LOT# OF OTHER ONYX INVOLVED: MODEL#: 105-7100-080; LOT#: 7913561; DOM: 11/03/2009; EXP: 08/01/2012. MODEL#: 105-7100-080; LOT#: 9387299; DOM: 12/13/2010; EXP: 11/01/2013. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVED DURING PROCEDURE. THE PATIENT WAS SLOW TO WAKE UP FROM ANESTHESIA AND PUPILS NOTED TO BE DILATED. CT SCAN SHOWED SUBDURAL HEMATOMA. THE FAMILY REQUESTED WITHDRAW OF CARE AND THE PATIENT EXPIRED ON (B)(6) 2011. SAME EVENT AS MDR# 2029214-2011-00068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9388490

    Patients

    Seq Age Sex Outcome Treatment
    1 Death