BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1051885 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00195
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    July 16, 2006
    Report Date
    April 29, 2008
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE OTHER: SUBJECT DEVICE WAS PLACED WITHOUT INCIDENT; HOWEVER, THE PT HAD 2 TIA'S (TRANSIENT ISCHEMIC ATTACK) AND STENT OCCLUSION NOTED IN FOLLOW UP VISITS. REQUESTS FOR FOLLOW UP INFO HAVE BEEN UNANSWERED TO DATE. THE REPORTED ADVERSE EVENT (TIA, STENT OCCLUSION) IS CONTAINED IN THE DEVICE DIRECTIONS FOR USE. BASED ON THE INFO 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 STENTING PROCEDURE TO TREAT INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE LEFT CAROTID PETROUS. THE PT HAS A HISTORY OF DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION, CAROTID ARTERY STENOSIS (70-89%) AND PRIOR STROKE. FOR THIS PROCEDURE IN 2006, PRE-PROCEDURE STENOSIS WAS 80%. THE PT "WAS PRE-MEDICATED WITH ASPIRIN AND CLOPIDOGREL." PRE-DILATION WAS PERFORMED WITH A BALLOON CATHETER, FOLLOWED BY IMPLANTATION OF THE SUBJECT DEVICE (STENT). RESIDUAL STENOSIS WAS 20%. IN A FOLLOW UP VISIT ON THE FOLLOWING MONTH, THE PT HAD A TIA (TRANSIENT ISCHEMIC ATTACK). CEREBRAL ANGIOGRAPHY SHOWED 60% OCCLUSION, RESULTING IN STENTING OF THE LEFT SUPRACLINOID. ON ELEVEN DAYS LATER, CEREBRAL ANGIOGRAPHY SHOWED NO EVIDENCE OF TARGET LESION RESTENOSIS, AS THE ISSUE HAD RESOLVED WITHOUT RESIDUAL EFFECTS. IN 2007, THE PT HAD A TIA. CEREBRAL ANGIOGRAPHY SHOWED 100% OCCLUSION OF THE STENTS, WHICH IS ONGOING/UNRESOLVED SINCE THE LAST VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP. WS040020

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R GATEWAY BALLOON CATHETER