BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM

    MDR report key: 1222563 · Received November 6, 2008

    Report

    Report Number
    1222563
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING A NEUROFORM STENT ON A PATIENT WHEN THE STENT DEPLOYED PREMATURELY IN THE PATIENT'S CAROTID ARTERY. THE STENT FLOATED DISTALLY AND COLLAPSED IN ON ITSELF. THE DOCTOR SUCCESSFULLY SNARED THE STENT AND REMOVED IT FROM THE PATIENT WHO WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT, INTERCRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORP. * 11913861

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR