BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4036879 · Received August 14, 2014

    Report

    Report Number
    2029214-2014-00487
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION) OFF OF THE VERT. ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE DISTAL SEGMENT OF THE CATHETER SEPARATED AND BECAME LODGED IN THE PICA (POSTERIOR INFERIOR CEREBELLAR ARTERY). THE PHYSICIAN STATED THERE WAS FRICTION EXPERIENCED DURING THE INJECTION. ON (B)(6) 2014, IT WAS REPORTED THE PATIENT WAS DOING FINE AND THE BROKEN CATHETER SEGMENT REMAINS IN THE PATIENT WITH NO FUTURE PLANS ON REMOVING IT. SAME EVENT AS MDR# 2029214-2014-00486.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487202 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 50067-060-1 9778448

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability