BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1051818 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00183
    Event Type
    Death
    Date Received
    May 21, 2008
    Date of Event
    April 14, 2006
    Report Date
    April 25, 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, PRIOR TO DISCHARGE, THE PT HAD A STROKE, PROLONGING HOSPITALIZATION, AND LATER DIED DUE TO CARDIAC ISSUES. REQUESTS FOR FOLLOW UP INFO HAVE BEEN UNANSWERED TO DATE. THE DEVICE DIRECTIONS FOR USE DETAILS THE REPORTED ADVERSE EVENTS (STROKE, DEATH). 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

    IT WAS REPORTED IN 2008, A STENTING PROCEDURE TO TREAT INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE LEFT VERTEBRAL AND LEFT VERTEBRO-BASILAR JUNCTION. THE PT HAD A HISTORY OF DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION AND PERIPHERAL VASCULAR DISEASE. THE PT ALSO HAD A HISTORY OF CAROTID ARTERY DISEASE, MYOCARDIAL INFARCTION, CHF (CONGENITAL HEART FAILURE), CAROTID ARTERY STENOSIS (LEFT CAROTID WITH 50-69% STENOSIS), AND PRIOR STROKE. FOR THIS PROCEDURE IN 2006, PRE-PROCEDURE STENOSIS WAS 68%. 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 10%. PRIOR TO DISCHARGE ON THE NEXT DAY, THE PT HAD A STROKE, PROLONGING HOSPITALIZATION. THE PT EXPIRED ON FIFTEEN DAYS LATER, DUE TO CARDIAC ISSUES.

    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. WS045015

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H MAVERICK BALLOON CATHETER