BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    MDR report key: 1010434 · Received February 5, 2008

    Report

    Report Number
    1010434
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT'S LEFT INTERNAL CAROTID ARTERY AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT. NO STENT WAS VISIBLE IN THE DELIVERY SYSTEM. THE SYSTEM WAS REMOVED FROM THE PATIENT AND INSPECTED - THERE WAS NO STENT IN THE DELIVERY SYSTEM. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 MICRODELIVERY STENT SYSTEM STENT, CAROTID NIM BOSTON SCIENTIFIC CORP. * 11204005

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR