BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6655938 · Received June 20, 2017

    Report

    Report Number
    1226348-2017-00075
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    October 21, 2008
    Report Date
    May 29, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 1226348-2017-00075, 2954740-2017-00176 AND 2954740-2017-00177 LITERATURE ARTICLE ATTACHED TO THIS REPORT. UDI UNAVAILABLE; LOT UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: 6F CORDIS XB MPC GUIDE CATHETER; PLATINUM TRANSEND MICROWIRE; PROWLER SELECT PLUS MICROCATHETER; X-PEDION 10 MICROWIRE; ECHELON-10 MICROCATHETER. NEITHER THE CATALOGUE NUMBER NOR THE LOT NUMBER WAS AVAILABLE THUS NEITHER DHR NOR FAL COULD BE COMPLETED. OCCLUSION OF THE CEREBRAL ARTERY AND THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE CODMAN EMBOLIC OILS AND IS LISTED IN THE IFU. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET ANEURYSM CHARACTERISTICS, COIL MASS BURDEN AND MEDICATION REGIMEN MAY HAVE CONTRIBUTED TO THE REPORT OF OCCLUSION OF THE ARTERY AND THROMBOSIS. THERE IS NO EVIDENCE OF MANUFACTURING RELATED ISSUES. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿STENTING BOTH BEFORE AND AFTER COILING OF A RUPTURED FUSIFORM BASILAR ANEURYSM TO OVERCOME MECHANICAL OCCLUSION CAUSED BY THROMBOSIS WITHIN THE COIL MASS¿ BY B. VARJANAND, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 15: 117-122, 2009, OCCLUSION OF THE PARENT ARTERY WAS REPORTED POST STENT-ASSISTED COIL EMBOLIZATION PROCEDURE. THE PATIENT WAS A (B)(6)-YEAR-OLD RIGHT-HANDED MAN WHO SUFFERED A HEADACHE FOLLOWED BY SEIZURES AND SYNCOPE ON (B)(6) 2008. CT SHOWED FOURTH VENTRICULAR BLOOD, A SMALL AMOUNT OF SUBARACHNOID HEMORRHAGE, AND A LEFT-SIDE PREPONTINE MASS. CT ANGIOGRAPHY DISCLOSED A FUSIFORM ANEURYSMAL DILATATION OF A TORTUOUS BASILAR TRUNK. ANGIOGRAPHY CONFIRMED LACK OF COLLATERALIZATION TO THE BASILAR TIP. THERE WAS NO ANTEROPOSTERIOR FLOW THROUGH EITHER PCOM. HALF OF A 13 X 43 PRESIDIO-18COIL WAS ADVANCED INTO THE ANEURYSM, FOLLOWED BY DEPLOYMENT OF THE DISTAL HALF OF A 4.5 X37MM ENTERPRISE STENT. REST OF THE STENT WAS DEPLOYED, FOLLOWED BY DEPLOYMENT OF THE REST OF THE FIRST COIL. THE ANEURYSM WAS THEN COILED WITH NINE CASHMERE-14 COILS (12 X 30, 12X 30, 12 X 19, 11X27, 11 X18, 9X 25, 9 X 22, 9 X 14, AND 7 X 11), WITH THE INFERIOR IRREGULARITY (24 LATERAL 14) ABLE TO BE SUCCESSFULLY PACKED. POST EMBOLIZATION ANGIOGRAPHY STARTING AT 10:40 SHOWED NO SIGN OF NON-TARGET EMBOLIZATION OR SLOWING OF THE TRANSIT TIME OF CONTRAST PAST THE COIL MASS FOR APPROXIMATELY 30 MINUTES, AND THE DECISION TO STOP THE CASE WAS MADE AT 11:04. MULTIPLE ANGIOGRAMS WERE OBTAINED IN AN ATTEMPT TO SEE ANY CLOT WITHIN THE VISUALIZABLE PORTIONS OF THE PARENT VESSEL AND THEN THE GUIDE CATHETER WAS PULLED BACK TO THE PROXIMAL RIGHT VERTEBRAL AND ANGIOGRAPHY WAS PERFORMED TO DOUBLE CHECK THE VERTEBRAL FOR ANY SIGN OF DISSECTION OR SPASM AT THE SITE OF THE TIP OF THE GUIDE CATHETER. SLOWING OF THE WASHOUT OF CONTRAST FROM THE RIGHT VERTEBRAL WAS NOTED, DESPITE A LACK OF A DELAY IN THE PASSAGE OF CONTRAST ACROSS THE COIL MASS. THREE CEREBRAL ANGIOGRAMS WERE THEN PERFORMED, AND SUDDENLY THERE WAS A MARKED SLOWING OF FLOW ACROSS THE ANEURYSM AT 11:29, APPROXIMATELY 50 MINUTES AFTER THE DETACHMENT OF THE FINAL COIL. THE GUIDE CATHETER WAS READVANCED INTO A WORKING POSITION AND THE ECHELON-10 MICROCATHETER LOADED WITH THE X-PEDION MICROWIRE WERE READVANCED INTO POSITION ACROSS THE NECK OF THE ANEURYSM, WHICH WAS LACED WITH 10 MG OF REOPRO. ANGIOGRAPHY IMMEDIATELY AFTER THIS LACING, AT 11:40 HOURS, 11 MINUTES AFTER NOTICING THE SLOWING, SHOWED COMPLETE PATENCY. THIS WAS THE FIRST ANGIOGRAM PERFORMED AFTER CROSSING THE STENT WITH THE MICROCATHETER. REOCCLUSION OF THE BASILAR WAS THEN SEEN FIVE MINUTES AFTER THE LACING WITH REOPRO. RE-TRAVERSAL OF THE STENT WITH THE MICROCATHETER WAS ACCOMPANIED BY A SUDDEN RELEASE OF CONTRAST INTO THE DISTAL VASCULATURE. THIS HAPPENED AS THE MICROCATHETER CROSSED THE PORTION OF THE PARENT VESSEL WHICH APPEARED BENT FORWARD IN A 90 DEGREE SHAPE ON THE 3D VIEWS OF THE ANEURYSM. ACCORDINGLY, THE ECHELON-10 WAS EXCHANGED FOR THE PROWLER SELECT PLUS USING A TRANSEND FLOPPY EXCHANGE WIRE, AND A SECOND ENTERPRISE STENT, THIS TIME A 4.5 X 28, WAS PLACED WITHIN THE FIRST. THREE SERIES OF CEREBRAL ANGIOGRAMS OVER 30 MINUTES SHOWED NO FURTHER TENDENCY FOR THE BASILAR TO OCCLUDE AND THE GUIDE CATHETER WAS THEN REMOVED AND THE SHEATH STITCHED IN. A PRE-PROCEDURAL HEAD CT SHOWED NO SIGNIFICANT CHANGE. THE BASILAR WAS FOUND TO BE WIDELY PATENT. THE PATIENT REGAINED HIS ABILITY TO MOVE HIS ARMS AND THEN HIS LEGS OVER TWO DAYS. FOLLOW-UP ANGIOGRAPHY ON (B)(6) SHOWED THAT THE COILING WAS STABLE AND THAT APART FROM A SMALL POCKET AT ITS UPPER ASPECT THE ANEURYSM WAS OCCLUDED. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOG/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435500 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention