BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3953667 · Received July 23, 2014

    Report

    Report Number
    2029214-2014-00432
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A CEREBELLAR AVM (ARTERIOVENOUS MALFORMATION). THE PATIENT'S ANATOMY WAS TORTUOUS. ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. POST ONYX INJECTION, IT WAS REPORTED THE DISTAL TIP OF THE CATHETER SEPARATED WITH A PIECE OF ONYX AS IT WAS BEING PULLED WITH SOME RESISTANCE AND THEY (CATHETER TIP AND PIECE OF ONYX) MIGRATED INTO THE MID SUPERIOR CEREBELLAR ARTERY CAUSING FLOW ARREST. PRIOR TO CATHETER SEPARATION, IT WAS REPORTED THE PHYSICIAN EMBOLIZED ONE PORTION OF THE AVM WITHOUT INCIDENT AND PULLED THE MARATHON TO ACCESS A DIFFERENT PORTION OF THE LESION THROUGH THE SUPERIOR CEREBELLAR ARTERY. THE ONYX EMBOLIZATION WAS SUCCESSFUL WITH 1CM OR LESS OF REFLUX PRIOR TO THE SEPARATION. ON (B)(6) 2014, IT WAS REPORTED THE PATIENT SUFFERED A STROKE AND WAS IN POOR CONDITION. ON (B)(6) 2014, THE PATIENT WAS EXTUBATED AND DOING WELL ACCORDING TO THE PHYSICIAN. ON (B)(6) 2014, IT WAS REPORTED THERE WILL BE NO ATTEMPTS TO REMOVE THE BROKEN CATHETER TIP AND ONYX AS THE PATIENT IS MAKING PROGRESS. SAME EVENT AS MDR# 2029214-2014-00431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431076 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability