BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2081986 · Received May 9, 2011

    Report

    Report Number
    1058196-2011-00212
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    January 24, 2010
    Report Date
    April 11, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 6FRENCH CHAPERONE CATHETER, 6FRENCH SHEATH, 5FRENCH DIAGNOSTICS CATHETER, 2X8 APEX BALLOON, PROWLER PLUS MICROCATHETER, AND PENUMBRA CATHETER. THERE WAS PATENCY OF THE RIGHT MCA DISTAL VASCULATURE. FIVE MG OF TPA WAS ADMINISTERED. NEXT A 1.5MM X 8MM APEX BALLOON WAS PLACED ACROSS THE M1 PARTIAL OCCLUSION AND CLOT MACERATION WAS PERFORMED. THE BALLOON WAS REMOVED AND AN ADDITIONAL 5MG OF TPA WAS ADMINISTERED WITH CONTINUED M1 OCCLUSION WITH IMPROVED FLOW INTO THE MCA WITH PATENCY OF THE RIGHT MCA DISTAL VASCULATURE. DELIVERY OF A 2MMX 8MM APEX BALLOON WAS UNSUCCESSFUL AT THE ARCH AND WAS THEREFORE REMOVED. A PROWLER PLUS WAS NAVIGATED INTO THE RIGHT M2 PAST THE THROMBUS AND A 37MM ENTERPRISE WAS PARTIALLY DEPLOYED MACERATING THE CLOT AND THROMBECTOMY WAS PREFORMED. M1 OCCLUSION WITH EXCELLENT FLOW INTO THE MCA M2 BRANCHES WAS REPORTED. POST USE OF THE ENTERPRISE M1 OCCLUSION WITH DIMINISHED FLOW INTO THE MCA M2 BRANCHES WAS NOTED. THERE WAS AN OCCLUSION OF THE RIGHT MCA BIFURCATION. FIVE MG OF TPA WAS ADMINISTERED. AN 054 PENUMBRA CATHETER WAS PLACED INTO THE RIGHT M1 AND THROMBECTOMY WAS PERFORMED. THERE WAS M1 PATENCY WITH EXCELLENT FLOW INTO THE MCA M2 BRANCHES. NO EVIDENCE OF VASCULITIS, ANEURYSM, OR AV SHUNTING IS SEEN. MAJOR VENOUS SINUSES ARE PATENT. SUCCESSFUL REVASCULARIZATION OF THE RIGHT M1 OCCLUSION WITH COMPLETE RESOLUTION OF THE CLOT FOLLOWING THROMBECTOMY AND THROMBOLYSIS WAS REPORTED WITH NO APPARENT PROCEDURAL COMPLICATIONS. THE ENTERPRISE VRD REMAINS IMPLANTED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORDS REVIEW CANNOT BE COMPLETED. AS OUTLINED IN THE INSTRUCTIONS FOR USE, THE INDICATED USE OF THE ENTERPRISE VRD IS TO PREVENT COILS FROM PROTRUDING OUT OF THE ANEURYSM INTO THE PARENT ARTERY. THE PHYSICAL MANIPULATION INHERENT IN THE THROMBECTOMY, ANGIOPLASTY AND STENT INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA AND PRE-EXISTING THROMBUS IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE EXISTING DISEASE PROCESS. WITH REVIEW OF THE PROVIDED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES RELATED TO THE DIMINISHED FLOW INTO THE MCA M2 BRANCHES AFTER OFF-LABEL USE OF THE ENTERPRISE VRD TO MACERATE THE CLOT IN THE M1. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    PER OFF LABEL USE REPORTING REQUIREMENTS, INFORMATION WAS RECEIVED REPORTING THAT IN ADDITION TO THROMBECTOMY, ANGIOPLASTY AND THROMBOLYTICS, THE ENTERPRISE VRD WAS USED TO SUCCESSFULLY TREAT A RIGHT M1 OCCLUSION IN A (B)(6) WHO PRESENTED WITH AN ACUTE STROKE. POST USE OF THE ENTERPRISE VRD THERE WAS DIMINISHED FLOW INTO THE MCA M2 BRANCHES WITH OCCLUSION OF THE RIGHT MCA BIFURCATION. THIS WAS FOLLOWED BY PENUMBRA ASPIRATION WITH FOLLOW-UP AND FINAL ANGIOGRAPHY DEMONSTRATING M1 PATENCY WITH EXCELLENT FLOW INTO THE M2 BRANCHES. THE PATIENT WAS ADMITTED WITH LEFT SIDED WEAKNESS AND APHASIA; ONSET 1.5 HOURS PRIOR TO PRESENTATION. NIHSS SCORE WAS 22 WITH DIAGNOSTIC STUDIES SHOWING A RIGHT M1 OCCLUSION, PRESERVED VOLUME, DECREASE FLOW. INITIAL ANGIOGRAPHY DEMONSTRATED OCCLUSION OF THE RIGHT MCA BIFURCATION. FIVE MG OF TPA WAS ADMINISTERED AND A PNEUMBRA CATHETER WAS PLACED IN THE RIGHT M1. POST ANGIOGRAPHY REPORTED M1 OCCLUSION WITH MINIMAL FLOW INTO THE MCA M2 BRANCHES AND WITH A SECOND ASPIRATION THERE WAS IMPROVED FLOW INTO THE MCA M2 BRANCHES.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention