BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3953028 · Received July 23, 2014

    Report

    Report Number
    2029214-2014-00436
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    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 ARE AS FOLLOWS: MODEL: 105-7100-060 / LOT: 9852961 DOM: 14 JAN 2014 EXP: 12 NOV 2016 (QTY. 2). (B)(4).

    Description of Event or Problem · 1

    (B)(4). TREATMENT OF A CEREBRAL ARTERIOVENOUS FISTULA. THE PATIENT PRESENTED WITH GLOBAL APHASIA AND HEMIPLEGIA. ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. DURING THE ONYX INJECTION, IT WAS REPORTED THERE WAS 2CM OF ONYX REFLUX AND THE MARATHON MICROCATHETER GOT STUCK INSIDE THE VESSEL AFTER INJECTING ONYX. UPON REMOVAL OF THE MICROCATHETER, THE MICROCATHETER SEPARATED AT 25CM FROM THE TIP AND THE BROKEN PIECE WAS LEFT INSIDE THE PATIENT AS THE REST OF THE MICROCATHETER WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED TO LEAVE THE BROKEN MICROCATHETER TIP INSIDE THE PATIENT BETWEEN THE EXTERNAL CAROTID ARTERY AND THE OCCIPITAL ARTERY SINCE THERE WAS NO RISK TO THE PATIENT. POST PROCEDURE, THE GLOBAL APHASIA AND HEMIPLEGIA WERE GETTING BETTER. SAME EVENT AS MDR # AS 2029214-2014-00435.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430368 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 9852961

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability