BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2927394 · Received January 23, 2013

    Report

    Report Number
    2029214-2013-00080
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    June 15, 2011
    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 DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: 105-7100-080 / LOT: 9402135 / DOM: 01/25/2011 / EXP: 12/31/2013 (QTY 4). MODEL: 105-7100-080 / LOT: 9387299 / DOM: 12/13/2010 / EXP: 11/30/2013. MODEL: 105-7100-060 / LOT: 9425108 / DOM: 03/24/2011 / EXP: 01/31/2014 (QTY 3). MODEL: 105-7100-060 / LOT: 9383028 / DOM: 12/01/2010 / EXP: 10/31/2013 (QTY 5). MODEL: 105-7100-080 / LOT: 9381247 / DOM: 11/24/2010 / EXP: 09/30/2013. MODEL: 105-7100-080 / LOT: 9383247 / DOM: 12/02/2010 / EXP: 12/01/2012 (QTY 2). MODEL: 105-7100-060 / LOT: 9433142 / DOM: 04/15/2011 / EXP: 01/31/2014. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ONYX PMS STUDY. TREATMENT OF A 5.5CM ARTERIOVENOUS MALFORMATION (AVM) LOCATED IN THE SUPERFICIAL PART OF THE RIGHT CEREBRUM, ELOQUENT AREA, NON-HEMORRHAGIC LESION. IT WAS REPORTED THAT THE PATIENT WAS FIRST TREATED WITH SIX ONYX 18 AND FIVE ONYX 34 ON (B)(6) 2011. THE PATIENT UNDERWENT ONYX EMBOLIZATION AGAIN ON (B)(6) 2011 IN WHICH EIGHT ONYX 18 AND TWO ONYX 34 WERE USED. ACCORDING TO THE PHYSICIAN, THE PATIENT DEVELOPED A SUBARACHNOID HEMORRHAGE (SAH) DUE TO A PERFORATION THAT OCCURRED WHILE INSERTING THE CATHETER THROUGH THE BRANCH OF THE ANTERIOR CEREBRAL ARTERY (ACA). ON (B)(6) 2011, THE PATIENT HAD A THIRD ONYX EMBOLIZATION TREATMENT IN WHICH ONE ONYX 18 AND ONE ONYX 34 WERE USED. THE PHYSICIAN COMMENTED THAT THE NORMAL PERFUSION WAS DISTURBED BY EMBOLISM; THEREFORE, THE PATIENT SUFFERED FROM BRAIN EDEMA, PARESIS OF LEFT ARM / LEG, AND SENSORY DISTURBANCE. IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE BRAIN EDEMA AND SENSORY DISTURBANCE AT THE TWELVE MONTH FOLLOW-UP. SAME EVENT AS MDR # 2029214-2013-00081.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32197 ONYX LIQUIDE EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9399360

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Disability