BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE

    MDR report key: 2061031 · Received April 12, 2011

    Report

    Report Number
    2061031
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ATTEMPT TO STENT THE ANEURYSM. AS THE STENT WAS ADVANCED INTO THE CATHETER IT GOT STUCK. AS IT WAS TRIED TO BE PULLED OUT, IT DEPLOYED OUT OF THE CATHETER TOO FAR TO RECAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT NJE CORDIS NEUROVASCULAR, INC. ENF451412 01428609

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR