BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN¿

    MDR report key: 2030020 · Received March 25, 2011

    Report

    Report Number
    2939204-2011-00144
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 14, 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

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS 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. SUBARACHNOID HEMORRHAGE (SAH) 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.

    Additional Manufacturer Narrative · 1

    STROKE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING IN THE PETRIOUS SECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA). HOWEVER, THE PATIENT SUFFERED "HYPERFUSION SYNDROME" RESULTING IN A SUBARACHNOID HEMMORHAGE IN THE TERRITORY OF THE TREATED VESSEL. MEDICATION WAS ADMINISTERED TO TREAT THE BLEED, AND THE PATIENT'S CONDITION IS LISTED AS ONGOING.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING IN THE PETRIOUS SECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA). HOWEVER, THE PATIENT SUFFERED "HYPERFUSION SYNDROME" RESULTING IN A SUBARACHNOID HEMMORHAGE IN THE TERRITORY OF THE TREATED VESSEL. MEDICATION WAS ADMINISTERED TO TREAT THE BLEED, AND THE PATIENT'S CONDITION IS LISTED AS ONGOING.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING IN THE PETRIOUS SECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA). HOWEVER, THE PATIENT SUFFERED "HYPERFUSION SYNDROME" RESULTING IN A IN AN ISCHEMIC STROKE IN THE TERRITORY OF THE TREATED VESSEL. MEDICATION WAS ADMINISTERED TO TREAT THE BLEED, AND THE PATIENT'S CONDITION IS LISTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN¿ STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WE0350150 13655403

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)