BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1050241 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00198
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 2, 2006
    Report Date
    April 30, 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 A STROKE AND SYMPTOMATIC TARGET LESION RESTENOSIS NOTED IN A FOLLOW UP VISIT. REQUESTS FOR FOLLOW UP INFORMATION HAVE BEEN UNANSWERED TO DATE. THE REPORTED ADVERSE EVENT (STROKE, RESTENOSIS) IS CONTAINED IN THE DEVICE DIRECTIONS FOR USE. THE SUBJECT DEVICE MAY HAVE BEEN USED OFF-LABEL BECAUSE IT SHOULD BE USED WITH A GATEWAY BALLOON CATHETER (UNK BALLOON CATHETER USED). 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 RIGHT MIDDLE CEREBRAL ARTERY. THE PT HAS A HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION, SEIZURE AND STROKE (TREATED WITH ANGIOPLASTY IN 2005). FOR THIS PROCEDURE IN EARLY 2006, PRE-PROCEDURE STENOSIS WAS 95%. 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. IN A FOLLOW UP VISIT ON THREE AND A HALF MONTHS LATER, THE PT WAS NOTED TO HAVE A STROKE, RESULTING IN HOSPITALIZATION. CEREBRAL IMAGING PERFORMED THE NEXT DAY SHOWED EVIDENCE OF SYMPTOMATIC TARGET LESION RESTENOSIS. THIS WAS TREATED WITH REVASCULARIZATION, WHICH OCCURRED ON THE NEXT DAY. THE STROKE RESOLVED WITH RESIDUAL EFFECTS ON APPROX SIX MONTHS LATER. CEREBRAL IMAGING PERFORMED ON APPROX ONE MONTH LATER, SHOWED NO EVIDENCE OF TARGET LESION RESTENOSIS; HOWEVER, PSEUDO OCCLUSION OF THE RIGHT M1 PROXIMAL SEGMENT (OUTSIDE OF SUBJECT DEVICE) WAS NOTED. CEREBRAL IMAGING PERFORMED IN 2007, SHOWED NO EVIDENCE OF TARGET LESION RESTENOSIS OR OTHER CHANGES.

    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 WS040015

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R BALLOON CATHETER (UNK MFG)