BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2927266 · Received January 23, 2013

    Report

    Report Number
    2029214-2013-00084
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    June 22, 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: 105-7100-060 / LOT: 9433142 / DOM: 04/15/2011 / EXP: 01/31/2014 (QTY 9). MODEL: 105-7100-080 / LOT: 9283247 / DOM: 09/28/2010 / EXP: 08/31/2013. MODEL: 105-7100-080 / LOT: 9373710 / DOM: 11/04/2010 / EXP: 10/31/2013. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY. TREATMENT OF A 6.0CM ARTERIOVENOUS MALFORMATION (AVM) LOCATED IN THE SUPERFICIAL PART OF THE LEFT CEREBRUM, ELOQUENT AREA, NON-HEMORRHAGIC LESION. IT WAS REPORTED THAT THE PATIENT WAS FIRST TREATED WITH TWELVE ONYX 18 AND ONE ONYX 34 ON (B)(6) 2011 RESULTING IN THE PATIENT DEVELOPING A CEREBRAL HEMORRHAGE AND 1/4 BLINDNESS ON THE UPPER RIGHT PART. THE PHYSICIAN COMMENTED THAT THE SYMPTOMS WERE CAUSED BY A 3 TO 4 CM HEMORRHAGE NEAR THE NIDUS INSIDE THE TEMPORAL LOBE THAT BECAME LARGER WITHIN 2 TO 3 DAYS AFTER THE EMBOLIZATION AND ALSO SUSPECTED THAT MANIPULATION OF THE CATHETER DURING THE PROCEDURE BROKE DOWN SMALL ARTERIES. THE PATIENT UNDERWENT A SECOND ONYX EMBOLIZATION ON (B)(6) 2011 IN WHICH ONE ONYX 18 WAS USED. THE EXCISION SURGERY WAS PERFORMED ON (B)(6) 2011 AND THE PATIENT RECOVERED FROM THE CEREBRAL HEMORRHAGE SIX MONTHS LATER, BUT THE BLINDNESS REMAINED. SAME EVENT AS MDR# 2029214-2013-00085

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32146 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9383028

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Disability