BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1050190 · Received May 23, 2008

    Report

    Report Number
    2939204-2008-00203
    Event Type
    Death
    Date Received
    May 23, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H050005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANGIOPLASTY AND IMPLANTATION OF A STENT IN THE LEFT VERTEBRAL ARTERY SEGMENT 4/POSTERIOR INFERIOR CEREBELLAR ARTERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY TECHNICAL DIFFICULTY. THE PHYSICIAN REPORTED THAT FOUR HOURS POST PROCEDURE, THE PATIENT HAD AN EPISODE OF BRADYCARDIA. A CT SCAN REVEALED A BLEED IN THE BRAIN STEM THAT THE PHYSICIAN STATED WAS "A KIND OF REPERFUSION BLEEDING, A KNOWN CLINICAL RISK FOR THIS TREATMENT". THE PHYSICIAN DOES NOT ALLEGE ANY MALFUNCTION OR NON CONFORMANCE OF THE STENT, BUT THAT THE EVENT WAS DUE TO "THE IMPROVED FLOW". THE PATIENT WAS REPORTED TO HAVE DIED DUE TO THE BLEEDING IN THE BRAIN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM NJE - NEUROVASCULAR STENT NJE BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION WE045015 11324312

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| O