BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX LIQUID EMBOLIC SYSTEM

    MDR report key: 1884888 · Received October 21, 2010

    Report

    Report Number
    MW5017900
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 21, 2010
    Manufacturer
    EV3 ENDOVASCULAR, INC, CORPORATE WORLD HEADQUARTERS/PERIPHERAL VASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONYX LIQUID EMBOLIC MATERIAL WAS USED TO EMBOLIZE THE ANEURYSMAL SAC AND FILL THE FEEDING VESSELS. UPON EXIT, THE MICROCATHETER BECAME STUCK IN THE SOLIDIFIED ONYX. QUESTION USER ERROR VS PRODUCT MALFUNCTION. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: ENDOSTENT LEAK/AORTIC ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX LIQUID EMBOLIC SYSTEM ONYX LIQUID EMBOLIC SYSTEM MFE EV3 ENDOVASCULAR, INC, CORPORATE WORLD HEADQUARTERS/PERIPHERAL VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1