BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 STENT SYSTEM

    MDR report key: 1221872 · Received November 4, 2008

    Report

    Report Number
    2939204-2008-00548
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR STENT INTERACTION WITH THE GUIDEWIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TREATING THE ANEURYSM, THE PHYSICIAN DEPLOYED THE STENT AT THE NECK OF THE ANEURYSM. HE TRIED TO ADVANCE THE GUIDEWIRE INTO THE ANEURYSM TO BEGIN COILING, HOWEVER, THE TIP OF THE GUIDEWIRE BECAME ENTANGLED WITH THE STENT. THE PHYSICIAN TRIED TO PULL THE GUIDEWIRE BACK, BUT IT WAS "TIED IN A KNOT" AROUND THE STENT. AS HE KEPT PULLING THE GUIDEWIRE, IT PULLED THE STENT PROXIMAL TO THE NECK OF THE ANEURYSM. AS THE STENT CAME BACK, THE GUIDEWIRE WAS UNTANGLED AND REMOVED FROM THE PT. THE PHYSICIAN DECIDED TO LET THE STENT ENDOTHELIALIZE FOR THIRTY DAYS AND ATTEMPT TO COIL THE ANEURYSM AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 STENT SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. SNF33015 11819637

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention BOSTON SCIENTIFIC TRANSCEND GUIDEWIRE