BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 3.5 X 9MM

    MDR report key: 3150623 · Received June 6, 2013

    Report

    Report Number
    3008853977-2013-00181
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2012
    Report Date
    May 28, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THROMBOSIS IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION, AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PATIENT COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE RERMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ANGIOPLASTY AND STENT PLACEMENT TO TREAT A BASILAR ARTERY STENOSIS. AT 12 MONTHS FOLLOW-UP THE PATIENT¿S MODIFIED RANKIN SCALE WAS MEASURED OF 0. SUBSEQUENT REVIEW OF IMAGING SHOWED THAT AT 17 MONTHS FOLLOW-UP THE PATIENT HAD COMPLETE STENT OCCLUSION PROBABLY DUE TO THROMBOSIS. THERE WERE NO CLINICAL SYMPTOMS OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ANGIOPLASTY AND STENT PLACEMENT TO TREAT A BASILAR ARTERY STENOSIS. AT 12 MONTHS FOLLOW-UP THE PATIENT¿S MODIFIED RANKIN SCALE WAS MEASURED OF 0. SUBSEQUENT REVIEW OF IMAGING SHOWED THAT AT 17 MONTHS FOLLOW-UP THE PATIENT HAD COMPLETE STENT OCCLUSION PROBABLY DUE TO THROMBOSIS. THERE WERE NO CLINICAL SYMPTOMS OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250315 F/G WINGSPAN STENT SYSTEM 3.5 X 9MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF 13143194

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other