BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 1789474 · Received July 27, 2010

    Report

    Report Number
    2029214-2010-00163
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 23, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVAL AS THEY WERE CONSUMED IN THE EVENT. MODEL# AND LOT# OF THE OTHER TWO ONYX VIALS INVOLVED IN THE EVENT: MODEL# 105-7100-060, LOT# 7641392, DOM: 07/2009, EXP: 06/2012. MODEL# 105-7100-060, LOT# 7853585, DOM: 10/2009, EXP: 08/2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE VIALS OF ONYX WAS USED IN AN AVM EMBOLIZATION TREATMENT PROCEDURE. DURING INJECTING ONYX INTO THE FEEDER OF THE SUPERIOR CEREBELLAR ARTERY, CEREBELLAR INFARCTION OCCURRED. THE PHYSICIAN COMMENTED THAT THE CAUSED OF THE CEREBELLAR INFARCTION WAS DUE TO PART OF THE ONYX MIGRATED INTO THE NORMAL CIRCULATION. IT WAS REPORTED THE PT'S INFARCTION HAS RECOVERED AND THE AVM WAS RESECTED ON (B)(6) 2010. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PT 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 105-7100-060 7948792

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL# 105-7100-060, LOT# 7641392