BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 989662 · Received January 30, 2008

    Report

    Report Number
    1058196-2008-00023
    Event Type
    Injury
    Date Received
    January 30, 2008
    Date of Event
    December 10, 2007
    Report Date
    January 3, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INDEX PROCEDURE, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA FOR MOTION AND PAIN CONTROL. ARTERIAL ACCESS WAS OBTAINED VIA THE PERCUTANEOUS RIGHT TRANSFEMORAL APPROACH. A 6 FRENCH SHEATH CATHETER WAS PLACED AND ATTACHED TO HEPARINIZED FLUSH SYSTEM. A 6 FRENCH ENVOY GUIDING CATHETER AND AN ANGLED GLIDEWIRE WERE ADVANCED THROUGH THE SHEATH TO THE (LIC) LEFT INTERNAL CAROTID ARTERY. DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED IN MULTIPLE PLANES INTRACRANIALLY TO ESTABLISH A SUITABLE WORKING PROJECTION. INJECTION OF THE LIC ARTERY DEMONSTRATED A 6MM WIDE NECK ANEURYSM OF THE OPHTHALMIC SEGMENT OF THE LIC ARTERY. AN ENTERPRISE STENT (4.5X22MM) WAS ADVANCED INTO THE PARACLINOID SEGMENT OF THE LIC ARTERY. THE STENT WAS DEPLOYED BUT MOVED PROXIMALLY AND DID NOT COVER THE REGION OF THE NECK OF THE ANEURYSM COMPLETELY. A SECOND SENT MEASURING 4.5X22MM IN LENGTH WAS THEN PLACED MORE DISTALLY AND WAS SUCCESSFUL IN COVERING THE FULL EXTENT OF THE NECK OF THE ANEURYSM. A PROWLER 14 MICROCATHETER WAS ADVANCED INTO THE ANEURYSM THROUGH THE STENT AND COIL EMBOLIZATION WAS PERFORMED. MICRUS CASHMERE COILS WERE USED TO PERFORM THE EMBOLIZATION. THE FIRST COIL WAS 6MMX15CM. SIX ADDITIONAL COILS OF VARIOUS SIZES AND LENGTHS WERE DEPLOYED INTO THE ANEURYSM. AN 8TH COIL WAS ATTEMPTED AT DEPLOYMENT BUT NOT DEPLOYED AND WAS DISCARDED. AT THE END OF THE PROCEDURE, THE CATHETERS WERE REMOVED AND HEMOSTASIS WAS ACHIEVED USING A VASOSEAL DEVICE AND A DESTAT PATCH ALONG WITH MANUAL PRESSURE WAS THE RIGHT GROIN. THERE WERE NO IMMEDIATE COMPLICATIONS, AND POST EMBOLIZATION, THERE IS COMPLETE OCCLUSION OF THE ANEURYSM WITH NO EVIDENCE OF THROMBOEMBOLIC COMPLICATIONS. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE OF AN OPHTHALMIC ANEURYSM LOCATED IN THE LIC ARTERY, THE ENTERPRISE STENT (4.5X22MM) MIGRATED AND DID NOT COVER THE ANEURYSM NECK. A SECOND 4.5X22MM ENTERPRISE WAS DEPLOYED TO COVER THE NECK. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 13261763

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ENVOY GUIDING CATHETER| PROWLER MICROCATHETER