BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 EZ- 4.5 X 20MM

    MDR report key: 3190356 · Received June 26, 2013

    Report

    Report Number
    3008853977-2013-00196
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPLICATIONS IS A KNOWN RISK 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. THE PROBABLE CAUSE OF THE REPORTED STENT MIGRATION IS PROCEDURAL FACTORS AS IT IS LIKELY THAT PROCEDURAL FACTORS DURING USE LIMITED DEVICE PERFORMANCE.

    Additional Manufacturer Narrative · 1

    (B)(4): SUBJECT DEVICE REMAINS IMPANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT AN ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THREE STENTS WERE USED TO COVER THE NECK OF THE ANEURYSM. WHEN THE PHYSICIAN APPROACHED THE ANEURYSM WITH THE MICROCATHETER TO DEPLOY A FOURTH STENT, THE CATHETER PUSHED THE PROXIMAL END OF THE THIRD STENT. THE PROXIMAL END OF THE THIRD STENT (THIS REPORT) MIGRATED INTO THE ANEURYSM. AS A RESULT, THE PHYSICIAN CHANGED THE TREATMENT STRATEGY FROM STENT ASSISTED TECHNIQUE TO USING COILS TO OCCLUDE THE INTERNAL CAROTID ARTERY. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDE PARALYSIS AND APHASIA. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT AN ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THREE STENTS WERE USED TO COVER THE NECK OF THE ANEURYSM. WHEN THE PHYSICIAN APPROACHED THE ANEURYSM WITH THE MICROCATHETER TO DEPLOY A FOURTH STENT, THE CATHETER PUSHED THE PROXIMAL END OF THE THIRD STENT. THE PROXIMAL END OF THE THIRD STENT (THIS REPORT) MIGRATED INTO THE ANEURYSM. AS A RESULT, THE PHYSICIAN CHANGED THE TREATMENT STRATEGY FROM STENT ASSISTED TECHNIQUE TO USING COILS TO OCCLUDE THE INTERNAL CAROTID ARTERY. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDE PARALYSIS AND APHASIA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289810 NEUROFORM 3 EZ- 4.5 X 20MM STENT, INTRAVASCULAR, NEUOVASCULAR NJE STRYKER NEUROVASCULAR CORK 15393946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4 GDC COILS (STRYKER)| 2 NEUROFORM EZ STENTS (STRYKER)| 29 COILS (MANUFACTURER UNKNOWN)