BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT

    MDR report key: 2083418 · Received May 10, 2011

    Report

    Report Number
    2939204-2011-00274
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    October 1, 2010
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE ALL MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON RELEASE. 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. HEMORRHAGE AND THE PATIENT OUTCOME OF DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE 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

    THE PATIENT UNDERWENT A SUCCESSFUL ANGIOPLASTY AND STENTING OF THE RIGHT INTERNAL CAROTID ARTERY. A CT SCAN IMMEDIATELY POST PROCEDURE REVEALED NO EVIDENCE OF INTRACRANIAL BLEEDING. A FEW HOURS POST PROCEDURE, THE PATIENT BECAME UNCONSCIOUS AND A CT SCAN REVEALED AN INTRAVENTRICULAR HEMORRHAGE WITH EMERGING HEMORRHAGIC STROKE. THE PATIENT UNDERWENT AN EMERGENT VENTRICULOSTOMY WITH THE PLACEMENT OF AN EXTRA VENTRICULAR SHUNT. THE PATIENT'S CONDITION DID NOT IMPROVE AND THE PATIENT WAS UNCONSCIOUS WITHOUT ANY MOVEMENTS AND WAS ON A VENTILATOR FOR RESPIRATORY FAILURE. DUE TO THE GRAVE PROGNOSIS, THE FAMILY DECIDED TO PLACE THE PATIENT ON COMFORT CARE AND THE PATIENT'S CONDITION SLOWLY DECLINED. THE PATIENT DIED NINE DAYS POST PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SUCCESSFUL ANGIOPLASTY AND STENTING OF THE RIGHT INTERNAL CAROTID ARTERY. A CT SCAN IMMEDIATELY POST PROCEDURE REVEALED NO EVIDENCE OF INTRACRANIAL BLEEDING. A FEW HOURS POST PROCEDURE, THE PATIENT BECAME UNCONSCIOUS AND A CT SCAN REVEALED AN INTRAVENTRICULAR HEMORRHAGE WITH EMERGING HEMORRHAGIC STROKE. THE PATIENT UNDERWENT AN EMERGENT VENTRICULOSTOMY WITH THE PLACEMENT OF AN EXTRA VENTRICULAR SHUNT. THE PATIENT'S CONDITION DID NOT IMPROVE AND THE PATIENT WAS UNCONSCIOUS WITHOUT ANY MOVEMENTS AND WAS ON A VENTILATOR FOR RESPIRATORY FAILURE. DUE TO THE GRAVE PROGNOSIS, THE FAMILY DECIDED TO PLACE THE PATIENT ON COMFORT CARE AND THE PATIENT'S CONDITION SLOWLY DECLINED. THE PATIENT DIED NINE DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WS0400150 12918709

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)