BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3950468 · Received July 22, 2014

    Report

    Report Number
    2029214-2014-00429
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 24, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BEEN RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL: 105-7000-060 / LOT: 9871287 DOM: 18 FEB 2014, EXP: 12 DEC 2016. MODEL: 105-7000-060 / LOT: 9877476 DOM: 04 MAR 2014, EXP: 08 JAN 2017. MODEL: NA / LOT: NA DOM: NA EXP: NA (QTY. 4).(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. DURING THE ONYX INJECTION, IT WAS REPORTED THE MARATHON CATHETER RUPTURED. A TOTAL OF SEVEN VIALS OF ONYX WERE USED. NO FURTHER INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427661 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 9861109

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability