BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 EZ- 4.5 X 20MM

    MDR report key: 2920375 · Received January 17, 2013

    Report

    Report Number
    3008853977-2013-00007
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H050002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THE DEVICE WAS USED AGAINST INSTRUCTIONS FOR USE. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN TORTUOUS ANATOMY, AS THE PHYSICIAN HAD BEGUN TO DEPLOY THE STENT, THE STENT SYSTEM UNEXPECTEDLY MOVED BACKWARD AND THE STENT DEPLOYED AT THE BOTTOM OF THE LESION. THE PHYSICIAN ATTEMPTED TO DEPLOY ANOTHER STENT TO FULLY COVER THE NECK OF THE ANEURYSM BUT WAS UNSUCCESSFUL AND THE PROCEDURE WAS STOPPED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN TORTUOUS ANATOMY, AS THE PHYSICIAN HAD BEGUN TO DEPLOY THE STENT, THE STENT SYSTEM UNEXPECTEDLY MOVED BACKWARD AND THE STENT DEPLOYED AT THE BOTTOM OF THE LESION. THE PHYSICIAN ATTEMPTED TO DEPLOY ANOTHER STENT TO FULLY COVER THE NECK OF THE ANEURYSM BUT WAS UNSUCCESSFUL AND THE PROCEDURE WAS STOPPED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN TORTUOUS ANATOMY, AS THE PHYSICIAN HAD BEGUN TO DEPLOY THE STENT, THE STENT SYSTEM UNEXPECTEDLY MOVED BACKWARD AND THE STENT DEPLOYED AT THE BOTTOM OF THE LESION. THE PHYSICIAN ATTEMPTED TO DEPLOY ANOTHER STENT TO FULLY COVER THE NECK OF THE ANEURYSM BUT WAS UNSUCCESSFUL AND THE PROCEDURE WAS STOPPED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25316 NEUROFORM 3 EZ- 4.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 15280862

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention