BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3173662 · Received June 17, 2013

    Report

    Report Number
    2029214-2013-00551
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    March 7, 2011
    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

    (B)(4).

    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: 8119133 / DOM: 01/20/2010 / EXP: 11/30/2012; MODEL: 105-7100-080 / LOT: 7876949 / DOM: 10/20/2009 / EXP: 08/31/2012. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6). TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION) MEASURING 2.0CM LOCATED IN THE SUPERFICIAL PART OF THE RIGHT CEREBRUM S/M GRADE: 1, NON-ELOQUENT AREA, HEMORRHAGIC LESION. IT WAS REPORTED THAT THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT ON (B)(6) 2010 INVOLVING TWO ONYX 18 AND 1 ONYX 34 IN WHICH A TOTAL OF 0.58 ML WERE USED. THE AVM WAS COMPLETELY EXCISED ON 06/28/2011. THE 6-MONTH FOLLOW-UP SHOWED NO ABNORMALITY IN THE NEUROLOGICAL FINDINGS AND BLOOD TEST; HOWEVER, SOME CHANGES WERE SEEN IN THE IMAGE FINDINGS AFTER THE AVM TREATMENT. THE 12-MONTH FOLLOW-UP SHOWED SCARRING OF THE EXCISED CAVITY AND EDEMA IN THE SURROUNDING AREA. THE PATIENT DID NOT SHOW UP FOR THE 24-MONTH FOLLOW-UP. NO OTHER INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274439 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 8119733

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability