BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 4.5 X 20MM

    MDR report key: 3230983 · Received July 17, 2013

    Report

    Report Number
    3008853977-2013-00242
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. VASOSPASM IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY, A STENT WAS PLACED ACROSS A STENOTIC LESION IN THE PETROUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (L-ICA). IMAGING CONFIRMED A MILD IMPROVEMENT IN THE STENOSIS INVOLVING THE STENTED PETROUS SEGMENT OF THE LEFT ICA. HOWEVER, A MILD VASOSPASM INVOLVING PETROUS AND CAVERNOUS SEGMENTS OF THE LEFT ICA OCCURRED. THE VASOSPASM WAS TREATED WITH 200MCG NITROGLYCERIN INTERARTERIALLY. THE PROCEDURE WAS COMPLETED WITH TWO OTHER STENTS. IMAGING SHOWED SUCCESSFUL STENT RECONSTRUCTION AND RECANALIZATION OF THE DISSECTED AND STENOTIC L-ICA. FOUR DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME IN A STABLE CONDITION.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY, A STENT WAS PLACED ACROSS A STENOTIC LESION IN THE PETROUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (L-ICA). IMAGING CONFIRMED A MILD IMPROVEMENT IN THE STENOSIS INVOLVING THE STENTED PETROUS SEGMENT OF THE LEFT ICA. HOWEVER, A MILD VASOSPASM INVOLVING PETROUS AND CAVERNOUS SEGMENTS OF THE LEFT ICA OCCURRED. THE VASOSPASM WAS TREATED WITH 200MCG NITROGLYCERIN INTERARTERIALLY. THE PROCEDURE WAS COMPLETED WITH TWO OTHER STENTS. IMAGING SHOWED SUCCESSFUL STENT RECONSTRUCTION AND RECANALIZATION OF THE DISSECTED AND STENOTIC L-ICA. FOUR DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330552 F/G WINGSPAN STENT SYSTEM 4.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF 13535585

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention MAVERICK BALLOON CATHETER (BOSTON SCIENTIFIC)