BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 2.5 X 15MM

    MDR report key: 4974193 · Received August 5, 2015

    Report

    Report Number
    3008853977-2015-00330
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 15, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK (MDR)
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, PATIENT DEATH, THROMBOSIS, STROKE AND VASOSPASM ARE KNOWN RISKS ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENT IMPLANT PROCEDURE, IN-STENT THROMBOSIS OCCURRED WHICH WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR (TPA), INTEGRILIN AND HEPARIN. IN ADDITION, THE PATIENT WAS GIVEN INTRA-ARTERIAL VERAPAMIL TO TREAT VASOSPASM. THE FOLLOWING DAY THE PATIENT SUFFERED CEREBRAL EDEMA AND INFARCT AND WAS TREATED WITH THREE PERCENT HYPERTONIC SALINE AND MANNITOL. THE PATIENT PROGRESSED TO BRAIN DEATH LATER IN THE DAY. IT IS UNKNOWN IF THE REPORTED EDEMA, INFARCT, AND PATIENT DEATH ARE RELATED TO THE STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENT IMPLANT PROCEDURE, IN-STENT THROMBOSIS OCCURRED WHICH WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR (TPA), INTEGRILIN AND HEPARIN. IN ADDITION, THE PATIENT WAS GIVEN INTRA-ARTERIAL VERAPAMIL TO TREAT VASOSPASM. THE FOLLOWING DAY THE PATIENT SUFFERED CEREBRAL EDEMA AND INFARCT AND WAS TREATED WITH THREE PERCENT HYPERTONIC SALINE AND MANNITOL. THE PATIENT PROGRESSED TO BRAIN DEATH LATER IN THE DAY. IT IS UNKNOWN IF THE REPORTED EDEMA, INFARCT, AND PATIENT DEATH ARE RELATED TO THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514922 NEUROFORM 3 EZ 2.5 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK (MDR) 17742908

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| O| R