BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 EZ- 4.5 X 20MM

    MDR report key: 3870062 · Received June 12, 2014

    Report

    Report Number
    3008853977-2014-00182
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 21, 2014
    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 HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED; THEREFORE, ANALYSIS CANNOT BE PERFORMED. THE PATIENT WAS TESTED FOR METAL ALLERGIES INCLUDING NICKEL AND COBALT CHROME, AND THE RESULTS WERE NEGATIVE, THE IMPLANTED NEUROFORM EZ STENT IS A NICKEL/TITANIUM ALLOY - NITINOL. HOWEVER, OTHER COMPETITOR (AXIUMCOILS (EV3) AND HYDROFRAME COILS AND VFC COILS (MICROVENTION) WERE PRESENT/IMPLANTED. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE CAUSE FOR THE REPORTED PATIENT ISSUE; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE MONTH POST PROCEDURE THE PATIENT WAS SUSPECTED TO BE SUFFERING FROM ASYMPTOMATIC ENCEPHALOPATHY DUE TO METAL ALLERGY. DURING THE INDEX PROCEDURE COMPETITOR COILS WERE IMPLANTED IN ADDITION TO THE STENT. THE PHYSICIAN TREATED THE PATIENT WITH STEROIDS (UNKNOWN TYPE AND DOSAGE). IT WAS REPORTED THAT THE PATIENT WAS TESTED FOR METAL ALLERGIES INCLUDING NICKEL AND COBALT CHROME, AND THE RESULTS WERE NEGATIVE. THE PATIENT WAS REPORTED TO BE DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE MONTH POST PROCEDURE THE PATIENT WAS SUSPECTED TO BE SUFFERING FROM ASYMPTOMATIC ENCEPHALOPATHY DUE TO METAL ALLERGY. DURING THE INDEX PROCEDURE COMPETITOR COILS WERE IMPLANTED IN ADDITION TO THE STENT. THE PHYSICIAN TREATED THE PATIENT WITH STEROIDS (UNKNOWN TYPE AND DOSAGE). IT WAS REPORTED THAT THE PATIENT WAS TESTED FOR METAL ALLERGIES INCLUDING NICKEL AND COBALT CHROME, AND THE RESULTS WERE NEGATIVE. THE PATIENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348259 NEUROFORM 3 EZ- 4.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 15423719

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HYDROFRAME COILS (MICROVENTION)| VFC COILS (MICROVENTION)| AXIUM COILS (EV3)