BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT

    MDR report key: 1942612 · Received December 30, 2010

    Report

    Report Number
    2939204-2010-01174
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE NOTED THAT THE STENT WAS IN ITS INTENDED LOCATION IN THE OUTER BODY AND THE INNER BODY WAS BUTTED UP AGAINST THE PROXIMAL STENT MARKERS. THE STENT WAS NOT PARTIALLY DEPLOYED AS REPORTED. THE OUTER BODY WAS FOUND TO BE STRETCHED ON THE PROXIMAL SHAFT UNDER THE STRAIN RELIEF AND 5.2CM DISTAL TO THE STRAIN RELIEF. IT WAS ALSO COMPRESSED ON THE DISTAL SHAFT. THE INNER BODY HYPOTUBE WAS KINKED. IT WAS ALSO NOTED TO HAVE SEPARATED 0.5CM FROM THE PROXIMAL END. A LARGE AMOUNT OF BLOOD WAS OBSERVED IN THE DEVICE, WHICH IS INDICATIVE THAT THE FLUSH WAS INADEQUATE. IT WAS NOT POSSIBLE TO DEPLOY THE STENT IN THE LABORATORY DUE THE FRICTION ENCOUNTERED AND THE DAMAGES NOTED TO THE DEVICE. THE CAUSE OF THE FRICTION EXPERIENCED BY THE PHYSICIAN CAN NOT BE DETERMINED BUT KNOWN POSSIBLE CAUSES ARE HIGHLY TORTUOUS ANATOMY AND INADEQUATE FLUSH. THE HIGH FRICTION MOST LIKELY CAUSED THE PHYSICIAN TO APPLY EXCESSIVE FORCE IN AN EFFORT TO DEPLOY THE STENT. THIS TENSILE FORCE CAN RESULT IN THE DAMAGES NOTED TO THE DEVICE. THEREFORE, OPERATIONAL CONTEXT IS THE MOST PROBABLE CAUSE OF THE DAMAGES NOTED TO THE DEVICE. HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED HEMORRHAGE WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    DIFFICULTIES WERE ENCOUNTERED AS THE PHYSICIAN ATTEMPTED TO ACCESS THE LESION IN THE TORTUOUS RIGHT INTERNAL CAROTID ARTERY/MIDDLE CEREBRAL ARTERY AND THE STENT WAS SUBOPTIMALLY DEPLOYED SO IT DID NOT FULLY COVER THE LESION. IT WAS REPORTED THAT ONCE THE STENT WAS DEPLOYED, IT DID NOT FULLY OPEN IN THE VESSEL AND DURING THE ATTEMPT TO PLACE THE STENT THE CATHETER SHAFT BROKE AFTER REPEATED MANIPULATIONS. THE PATIENT WAS REPORTED TO SUFFER A "VESSEL HEMORRHAGE" AND WAS SENT TO SURGERY FOR FURTHER TREATMENT. THE PATIENT WAS REPORTED TO BE STABLE AFTER THE INTRACRANIAL PRESSURE WAS DECREASED. THE PATIENT'S RIGHT OCULOMOTOR NERVE WAS SLIGHTLY COMPRESSED BY THE HEMATOMA AND HAD "PUPIL AMPLIFY SYMPTOM". NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DIFFICULTIES WERE ENCOUNTERED AS THE PHYSICIAN ATTEMPTED TO ACCESS THE LESION IN THE TORTUOUS RIGHT INTERNAL CAROTID ARTERY/MIDDLE CEREBRAL ARTERY AND THE STENT WAS SUBOPTIMALLY DEPLOYED SO IT DID NOT FULLY COVER THE LESION. IT WAS REPORTED THAT ONCE THE STENT WAS DEPLOYED, IT DID NOT FULLY OPEN IN THE VESSEL AND DURING THE ATTEMPT TO PLACE THE STENT THE CATHETER SHAFT BROKE AFTER REPEATED MANIPULATIONS. THE PATIENT WAS REPORTED TO SUFFER A "VESSEL HEMORRHAGE" AND WAS SENT TO SURGERY FOR FURTHER TREATMENT. THE PATIENT WAS REPORTED TO BE STABLE AFTER THE INTRACRANIAL PRESSURE WAS DECREASED. THE PATIENT'S RIGHT OCULOMOTOR NERVE WAS SLIGHTLY COMPRESSED BY THE HEMATOMA AND THERE WAS "PUPIL AMPLIFY SYMPTOM". NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WE0300150 12907183

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention