BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 1052015 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00180
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE OTHER: THE SUBJECT DEVICE DISLODGED; HOWEVER, IT FULLY DEPLOYED, WAS WELL APPOSED AND WAS WELL POSITIONED. FOLLOW UP REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN UNANSWERED TO DATE. THE PHYSICIAN FELT THE EVENT WAS UNRELATED TO THE DEVICE (PHYSICIAN FELT THAT PROCEDURAL FACTORS WERE POSSIBLE CONTRIBUTORS). BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2008, A STENT ASSISTED COILING PROCEDURE OF A LEFT INTERNAL CAROTID ARTERY ANEURYSM. WHILE ATTEMPTING TO ADVANCE A MICROCATHETER OVER A GUIDEWIRE, THE SUBJECT DEVICE (STENT) DISLODGED INTO THE ANEURYSM. THE SUBJECT DEVICE FULLY DEPLOYED, WAS WELL APPOSED AND WAS WELL POSITIONED. THE PATIENT WAS STABLE POST PROCEDURE AND DID NOT SUFFER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXCELSIOR SL10 MICROCATHETER| GUIDEWIRE (UNKNOWN MFG)