BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 1940899 · Received December 23, 2010

    Report

    Report Number
    2029214-2010-00278
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    August 3, 2010
    Report Date
    December 9, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL AS IT WAS CONSUMED IN THE EVENT. MODEL # AND LOT# OF OTHER ONYX INVOLVED: MODEL#: 105-7100-060, LOT#: 8387102, DOM: 04/2010, EXPIRATION DATE: 02/2013. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. DURING PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE AND THE PT HAD SAH. THE AVM WAS REMOVED VIA SURGICAL INTERVENTION. SAME EVENT AS MDR# 2029214-2010-00277.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-080 8387103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention