BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1050243 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00197
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    October 24, 2006
    Report Date
    April 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIV.
    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 TIA (TRANSIENT ISCHEMIC ATTACK) PRIOR TO DISCHARGE. REQUEST FOR FOLLOW UP INFO HAVE BEEN UNANSWERED TO DATE. THE REPORTED ADVERSE EVENT (TIA) 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 (BALLOON CATHETER USED UNK MFG). 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 BASILAR TRUNK. THE PT HAS A HISTORY OF LEFT CAROTID ARTERY STENOSIS (50-69%), PRIOR STROKE, AND EXTRACRANIAL REVASCULARIZATION WITH AN INTERVENTION IN 2006. FOR THIS PROCEDURE, ON APPROX FOUR MONTHS LATER, 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 ON THE NEXT DAY, THE PT HAD A TIA (TRANSIENT ISCHEMIC ATTACK). AS WELL, A PSEUDOANEURYSM WAS OBLITERATED. THESE ISSUES RESOLVED WITHOUT RESIDUAL EFFECTS THE FOLLOWING DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention BALLOON CATHETER (UNK MFG)