BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3155122 · Received June 8, 2013

    Report

    Report Number
    2029214-2013-00533
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    October 18, 2010
    Report Date
    May 24, 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: 7853585 - DOM: 10/07/2009 - EXP: 08/31/2012 (QTY 2). MODEL# 105-7100-080, LOT: 7611060 - DOM: 07/09/2009- EXP: 04/30/2012. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) STUDY. TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION) MEASURING 2.9CM LOCATED AT THE SUPERFICIAL PART OF THE LEFT CEREBRUM, S/M GRADE: 1, ELOQUENT AREA, NON-HEMORRHAGIC LESION. IT WAS REPORTED THAT THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT TWO TIMES. THE FIRST TIME WAS ON (B)(6) 2010, INVOLVING ONE ONYX 18 AND ONE ONYX 34 IN WHICH A TOTAL OF 0.775ML WAS USED. THE SECOND PROCEDURE WAS ON (B)(6) 2010, INVOLVING TWO ONYX 18 AND A TOTAL OF 2.2ML WAS USED. THE AVM WAS COMPLETED EXCISED ON (B)(6) 2010 AND 6-MONTH / 12-MONTH FOLLOW-UPS SHOWED POST-TREATMENT AND EDEMA IMPROVING IN THE LOCATION OF THE EXCISED AVM. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257521 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 7853585

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability