BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT

    MDR report key: 2031852 · Received March 28, 2011

    Report

    Report Number
    2939204-2011-00150
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 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. VESSEL RUPTURE 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

    THE PATIENT UNDERWENT SUCCESSFUL STENTING IN THE LEFT INTERNAL CAROTID ARTERY (ICA). HOWEVER, THE PATIENT SUFFERED AN ARTERIAL RUPTURE RESULTING IN A HEMORRHAGE, LOCATION UNKNOWN. NO INTERVENTION WAS GIVEN. THE PATIENT IS CURRENTLY STILL IN THE INTENSIVE CARE UNIT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENTING IN THE LEFT INTERNAL CAROTID ARTERY (ICA). HOWEVER, THE PATIENT SUFFERED AN ARTERIAL RUPTURE RESULTING IN A HEMORRHAGE, LOCATION UNKNOWN. NO INTERVENTION WAS GIVEN. THE PATIENT IS CURRENTLY STILL IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WE0450200 13851937

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention GATEWAY BALLOON (BOSTON SCIENTIFIC)