BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1051889 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00182
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 13, 2007
    Report Date
    April 25, 2008
    Manufacturer
    NEUROVASCULAR, A DIVISIONOF 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

    SUBJECT DEVICE WAS PLACED WITHOUT ISSUE, AS THERE WERE NO COMPLICATIONS LISTED DURING THE PROCEDURE. HOWEVER, THE PT HAD RIGHT HAND THUMB NUMBNESS, ASYMPTOMATIC RESTENOSIS, AND A TIA (TRANSIENT ISCHEMIC ATTACK) NOTED IN FOLLOW UP VISITS. REQUESTS FOR FOLLOW UP INFO HAVE BEEN UNANSWERED TO DATE. THE DEVICE DIRECTIONS FOR USE DETAILS THE REPORTED EVENTS AS OBSERVED ADVERSE EVENTS (TIA, NEUROLOGICAL SYMPTOMS) OR POTENTIAL ADVERSE EVENTS (RESTENOSIS). 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 ON APRIL 25, 2008, A STENTING PROCEDURE TO TREAT INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE LEFT CAROTID PETROUS. THE PATIENT HAD A HISTORY OF DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION, CAROTID ARTERY STENOSIS IN THE LEFT CAROTID, AND EXTRACRANIAL REVASCULARIZATION TREATMENT IN 2006. FOR THIS PROCEDURE ON THE FOLLOWING MONTH, PRE-PROCEDURE STENOSIS WAS 85%. THE PATIENT "...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 0%. "NO COMPLICATIONS REPORTED DURING PROCEDURE." DURING FOLLOW UP VISITS, IT WAS REPORTED THAT THE PT HAD RIGHT HAND THUMB NUMBNESS AND A TIA (TRANSIENT ISCHEMIC ATTACK). ASYMPTOMATIC RESTENOSIS OF THE TREATED LESION WAS ALSO NOTED. AN ANGIOPLASTY WAS PLANNED TO TREAT THE RESTENOSIS; HOWEVER, SUBSEQUENT CEREBRAL IMAGING SHOWED THAT THE ANGIOPLASTY WASN'T NECESSARY, AS THE RESTENOSIS HAD DECREASED. THE RIGHT HAND THUMB NUMBNESS WAS TREATED WITH UNSPECIFIED MEDICATIONS AND RESOLVED WITHOUT RESIDUAL EFFECTS FOUR MONTHS LATER. THE PT WAS HOSPITALIZED IN RESPONSE TO THE TIA AND RESOLVED WITHOUT RESIDUAL EFFECTS IN 20007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R GATEWAY BALLOON CATHETER