BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT

    MDR report key: 2042519 · Received April 6, 2011

    Report

    Report Number
    2939204-2011-00175
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. TIA (TRANSIENT ISCHEMIC ATTACK) IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THREE MONTHS POST SUCCESSFUL STENTING OF THE MIDDLE CEREBRAL ARTERY (MCA), THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) IN THE REGION OF THE TREATED VESSEL. IT WAS NOTED AT FOLLOW-UP ONE MONTH POST PROCEDURE THE PATIENT STOPPED TAKING CLOPIDGREL. THE TIA RESOLVED THE SAME DAY WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THREE MONTHS POST SUCCESSFUL STENTING OF THE MIDDLE CEREBRAL ARTERY (MCA), THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) IN THE REGION OF THE TREATED VESSEL. IT WAS NOTED AT FOLLOW-UP ONE MONTH POST PROCEDURE THE PATIENT STOPPED TAKING CLOPIDOGREL. THE TIA RESOLVED THE SAME DAY WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WE0250090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention