BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM3 MICRODELIVERY STENT SYSTEM

    MDR report key: 797840 · Received December 15, 2006

    Report

    Report Number
    6000078-2006-00600
    Event Type
    Malfunction
    Date Received
    December 15, 2006
    Date of Event
    November 21, 2006
    Report Date
    November 28, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV
    Product Code
    NJE
    PMA / PMN Number
    h020002 / s4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS, HOWEVER, THE INVESTIGATION HAS NOT YET BEGUN. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL FOLLOW UPON COMPLETION OF THE INVESTIGATION. ADD'L 510K#: H020002 /S5.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED DURING A STENT ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, HE PLACED A STENT ACROSS THE OPTHALMIC ARTERY. THE STENT REPORTEDLY MOVED DURING ACCESS WITH A MICROCATHETER INTO THE PROXIMAL PORTION OF THE ANEURYSM. THE PHYSICIAN REPORTEDLY CONTINUED TO COIL. THE DETACHABLE COIL REPORTEDLY BECAME STRETCHED ON THE STENT, AND THE STENT FRACTURED. THE PHYSICIAN REMOVED THE STRETCHED COIL, MICROCATHETER AND FRACTURED STENT PORTION WITHOUT ANY ADDITIONAL ISSUES. THE PATIENT WAS REPORTEDLY AT BASELINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM3 MICRODELIVERY STENT SYSTEM (NJE) INTRACRANIAL STENT NJE BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV SNF34520 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR GDC 18 COILS (18 TOTAL)| 1018 MICROCATHETER