BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2927276 · Received January 23, 2013

    Report

    Report Number
    2029214-2013-00082
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    October 15, 2010
    Report Date
    January 8, 2013
    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.THE OTHER DEVICE INVOLVED IN THE EVENT IS:MODEL: 105-7100-080 / LOT: 8990684 / DOM: 07/21/2010 / EXP: 04/30/2013.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A 2.0CM ARTERIOVENOUS MALFORMATION (AVM) LOCATED IN THE SUPERFICIAL PART OF THE LEFT CEREBRUM, NON-ELOQUENT AREA, NON-HEMORRHAGIC LESION. IT WAS REPORTED THAT THE PATIENT WAS FIRST TREATED ON (B)(6) 2010 WITH THREE ONYX 18 AND TWO ONYX 34; HOWEVER, THE PHYSICIAN CONFIRMED THAT THE MICROCATHETER WAS VERY DIFFICULT TO REMOVE DURING THE PROCEDURE DUE TO ONYX REFLUX. THE CATHETER WAS EVENTUALLY REMOVED AND EXCISION SURGERY WAS ALSO PERFORMED ON THE SAME DAY. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT HAS MDR# 2029214-2013-00083.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32549 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 8889932

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Disability