BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX, AVM

    MDR report key: 3137758 · Received May 30, 2013

    Report

    Report Number
    2029214-2013-00516
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    December 8, 2012
    Report Date
    May 13, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: 105-7100-060, LOT: 9434047 / DOM: 04/19/2011 / EXP: 01/31/2014; MODEL: 105-7100-080, LOT: 9372420 / DOM: 11/02/2010 / EXP: 09/30/2013 ; MODEL: 105-7100-080, LOT: 9283247 / DOM: 09/29/2010 / EXP: 08/31/2013. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT SIDED TRANSVERSE-SIGMOID SINUS DURAL AVF (ARTERIOVENOUS FISTULA) AND ICH (INTRACEREBRAL HEMORRHAGE). IT WAS REPORTED THAT THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT AND SUFFERED A DIFFUSED SUBDURAL HEMATOMA IMMEDIATELY AFTERWARDS AND SUBSEQUENTLY EXPIRED 10 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238941 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9551478

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death