BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 EZ- 2.5 X 20MM

    MDR report key: 3192428 · Received June 27, 2013

    Report

    Report Number
    3008853977-2013-00204
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THROMBOSIS AND NEUROLOGICAL DEFICIT ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    SIX DAYS POST STENT ASSISTED EMBOLIZATION OF THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM), THE STENT THROMBOSIS OCCURRED. THE PATIENT WAS TREATED WITH CILOSTAZOL 100MG/DAY AND CLOPIDOGREL 75MG/DAY. THE STENT THROMBOSIS RESULTED IN PARALYSIS ON THE RIGHT SIDE OF THE BODY. THE PATIENT¿S MODIFIED RANKIN SCALE WAS MEASURED OF 3 AFTER THE EVENT. THE PATIENT IS STILL IN THE HOSPITAL.

    Description of Event or Problem · 1

    SIX DAYS POST STENT ASSISTED EMBOLIZATION OF THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM), THE STENT THROMBOSIS OCCURRED. THE PATIENT WAS TREATED WITH CILOSTAZOL 100MG/DAY AND CLOPIDOGREL 75MG/DAY. THE STENT THROMBOSIS RESULTED IN PARALYSIS ON THE RIGHT SIDE OF THE BODY. THE PATIENT¿S MODIFIED RANKIN SCALE WAS MEASURED OF 3 AFTER THE EVENT. THE PATIENT IS STILL IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293222 NEUROFORM 3 EZ- 2.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 15376823

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 8 TARGET COILS (STRYKER)