BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2882325 · Received December 20, 2012

    Report

    Report Number
    2029214-2012-00749
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    March 12, 2012
    Report Date
    December 4, 2012
    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.OTHER DEVICES INVOLVED IN THE EVENT ARE:MODEL: 105-7100-080; LOT: 7611060; DOM: 07/09/2009; EXP: 04/30/2012.MODEL: 105-7100-080; LOT: 7567358; DOM: 07/08/2009; EXP: 04/30/2012.MODEL: 105-7100-060; LOT: 7554862; DOM: 06/19/2009; EXP: 05/31/2012.MODEL: 105-7100-060; LOT: 7426893; DOM: 05/26/2009; EXP: 04/30/2012.MODEL: 105-7100-060; LOT: 7641392; DOM: 07/27/2009; EXP: 06/30/2012.MODEL: 105-7100-080; LOT: 7633194; DOM: 07/16/2009; EXP: 05/31/2012.(B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE IS PART OF THE (B)(6) STUDY. TREATMENT OF AN ARTERIOVENOUS MALFORMATION DEEPLY LOCATED IN THE CEREBRUM, NON-ELOQUENT AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ONYX EMBOLIZATION ON (B)(6) 2009 USING THREE ONYX 34 AND ANOTHER ONYX EMBOLIZATION ON (B)(6) 2010 USING THREE ONYX 18 AND ONE ONYX34. THE PATIENT HAD LEFT HEMIPLEGIA FOLLOWING THE PROCEDURE. FOLLOW-UPS WERE CONDUCTED SIX AND TWELVE MONTHS POST SURGERY WITH NO ABNORMALITIES REPORTED. DURING A FOLLOW-UP CONDUCTED 24 MONTHS POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT STILL HAD LEFT HEMIPLEGIA AND AN OLD CEREBRAL INFARCTION. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-080 7611060

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability