BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 4.0 X 30MM

    MDR report key: 7356234 · Received March 20, 2018

    Report

    Report Number
    3008881809-2018-00125
    Event Type
    Death
    Date Received
    March 20, 2018
    Date of Event
    October 27, 2012
    Report Date
    April 18, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, STROKE, DEATH, AND STENT THROMBOSIS ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A GIANT ANEURYSM AT THE BASILAR ARTERY BY Y-STENTING TECHNIQUE. APPROXIMATELY 1 MONTH POST-PROCEDURE, THE STENT (SUBJECT DEVICE) WAS PARTIALLY OCCLUDED DUE TO A THROMBOSIS. THE PATIENT WAS TREATED TWICE WITH INTRA-ARTERIAL TISSUE PLASMINOGEN ACTIVATOR (TPA). THE PATIENT SUFFERED A CEREBELLAR STROKE AND DECEASED. ACCORDING TO THE FACILITY, THE STROKE AND DEATH WERE POSSIBLY RELATED TO THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A GIANT ANEURYSM AT THE BASILAR ARTERY BY Y-STENTING TECHNIQUE. APPROXIMATELY 1 MONTH POST-PROCEDURE, THE STENT (SUBJECT DEVICE) WAS PARTIALLY OCCLUDED DUE TO A THROMBOSIS. THE PATIENT WAS TREATED TWICE WITH INTRA-ARTERIAL TISSUE PLASMINOGEN ACTIVATOR (TPA). THE PATIENT SUFFERED A CEREBELLAR STROKE AND DECEASED. ACCORDING TO THE FACILITY, THE STROKE AND DEATH WERE POSSIBLY RELATED TO THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197806 NEUROFORM 3 EZ 4.0 X 30MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 14363927

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R