BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1050225 · Received May 22, 2008

    Report

    Report Number
    2939204-2008-00202
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 18, 2006
    Report Date
    May 14, 2008
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    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

    SUBJECT DEVICE WAS PLACED WITHOUT INCIDENT; HOWEVER, THE PT HAD AN ISCHEMIC STROKE PRIOR TO DISCHARGE. REQUESTS FOR FOLLOW UP INFO HAVE BEEN UNANSWERED TO DATE. THE REPORTED ADVERSE EVENT (STROKE) IS CONTAINED IN THE DEVICE DIRECTIONS FOR USE. THE SUBJECT DEVICE WAS USED OFF-LABEL BECAUSE IT SHOULD BE USED WITH A GATEWAY BALLOON CATHETER. 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

    A STENTING PROCEDURE TO TREAT INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE LEFT MIDDLE CEREBRAL ARTERY WAS REPORTED ON MAY 14, 2008. THE PT HAS A HISTORY OF DIABETES MELLITUS, HYPERTENSION AND PRIOR STROKE. THE PT HAD A TIA (TRANSIENT ISCHEMIC ATTACK) IN 2006. FOR THIS PROCEDURE ON THE SAME DAY, 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 IS UNK. PRIOR TO DISCHARGE, THE PT HAD AN ISCHEMIC STROKE, AND WAS TREATED WITH MEDICATION (PROLONGING HOSPITALIZATION - RELEASED AFTER 39 DAYS). THE STROKE RESOLVED WITH RESIDUAL EFFECTS IN THE SAME MONTH. FOLLOW UP CEREBRAL IMAGING FOUND NO EVIDENCE OF TARGET LESION RESTENOSIS.

    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 CORPORATION WS025009

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R MAVERICK BALLOON CATHETER