BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3800985 · Received May 8, 2014

    Report

    Report Number
    2029214-2014-00263
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. RADIO-OPACITY TESTS WERE PERFORMED ON RETAINED SAMPLES FROM THE SAME LOTS AND WERE FOUND TO BE WITHIN SPECIFICATIONS. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: 105-7100-060 / LOT: 9852961, DOM: 14 JAN 2014 EXP: 12 NOV 2016 (QTY. 5). MODEL: 105-7100-060 / LOT: 9869584, DOM: 13 FEB 2014 EXP: 19 DEC 2016. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT INVOLVING 7 ONYX VIALS. DURING THE ONYX INJECTION NEAR THE END OF THE PROCEDURE, IT WAS REPORTED THAT THERE WAS LOW RADIOPACITY OF THE ONYX AS WELL AS IN CONSISTENCY AS IT WAS COMING OUT OF THE CATHETER. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277286 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9852955

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability