BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1689581 · Received May 14, 2010

    Report

    Report Number
    1058196-2010-00117
    Event Type
    Injury
    Date Received
    May 14, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 21, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITH PARTIAL DEPLOYMENT OF THE ENTERPRISE VRD, THE EMBOLI WAS ENTRAPPED AGAINST THE VESSEL WALL BY THE ENTERPRISE STENT RESULTING IN IMMEDIATE RECANALIZATION OF TIMI 2. THE RE-OCCLUDED ARTERY WAS RE-OPENED BY STENT RECAPTURE. THERE WAS NO DISTAL MIGRATION OR EMBOLIZATION OF THE ENTRAPPED EMBOLI VISIBLE ON ANGIOGRAM. FOLLOW-UP MR ANGIOGRAM REVEALED PERSISTENT PATENCY OF THE ARTERY. WITH REVIEW OF THE CITED REFERENCES, ADDITIONAL INFORMATION WAS NOTED IN THE ON LINE CASE REPORT PUBLISHED IN NEURORADIOLOGY 2009; 51:541-44. EPUB 2009 MAY 8. "TEMPORARY STENTING AND RETRIEVAL OF THE SELF EXPANDABLE, INTRACRANIAL STENT IN ACUTE MIDDLE CEREBRAL ARTERY OCCLUSION," SUH, SH, LEE KY, HONG CK, ET AL. THE AUTHORS ACKNOWLEDGE THE OFF-LABEL USE OF THE DEVICE. THE (B)(6) PATIENT WAS ADMITTED WITH ACUTE ONSET OF LEFT SIDED WEAKNESS AND DYSARTHRIA OF 2 HOUR DURATION. CT SHOWED A HYPERDENSE RIGHT MCA SIGN WITHOUT HEMORRHAGE AND CT ANGIOGRAPHY REVEALED SEVERE STENOSIS OF THE PROXIMAL RIGHT ICA AND OCCLUSION OF THE RIGHT MCA. TPA WAS ADMINISTERED IN THE EMERGENCY ROOM WITHOUT FULL RECOVERY AFTER 20 MINUTES; THEREFORE IT WAS DETERMINED TO PROCEED WITH INTRA-ARTERIAL THERAPY AND CAROTID ARTERY STENTING. ANGIOGRAPHY CONFIRMED COMPLETE OCCLUSION OF THE RIGHT MCA AND SEVERE STENOSIS OF THE RIGHT COMMON CAROTID ARTERY. UNEVENTFUL STENTING OF THE RIGHT PROXIMAL ICA WITH AN ANGIOGUARD EMBOLIC PROTECTION DEVICE AND PRECISE STENT WAS PERFORMED IN ORDER TO SECURE ACCESS TO THE DISTAL OCCLUSIVE SEGMENT. A PROWLER PLUS MICROCATHETER WAS ADVANCED TO THE OCCLUDED SEGMENT FOLLOWED BY INFUSION OF UROKINASE INTO THE THROMBUS AND MECHANICAL THROMBOLYSIS BY PASSING THE MICROCATHETER AND MICROWIRE REPEATEDLY THROUGH THE THROMBUS. RECANALIZATION WAS NOT ACCOMPLISHED; THEREFORE A 28MM ENTERPRISE STENT WAS DELIVERED ACROSS THE OCCLUDED SEGMENT VIA THE MICROCATHETER. ALMOST 2/3 OF THE STENT WAS DEPLOYED ACROSS THE THROMBOTIC SEGMENT WITH CONTROL ANGIOGRAPHY SHOWING IMMEDIATE RESTORATION OF BLOOD FLOW ACROSS THE STENTED SEGMENT OF THE RIGHT MCA. A SECOND MICROCATHETER WAS ADVANCED INTO THE PROXIMAL MCA WITH ADDITIONAL UK ADMINISTERED IN ORDER TO DISSOLVE THE RESIDUAL THROMBUS TRAPPED BY THE STENT. DELAYED ANGIOGRAPHY SHOWED RE-OCCLUSION OF THE RIGHT MCS BY TRAPPED THROMBUS AT DISTAL ENDS OF THE STENT AND ALTHOUGH IT WAS CONSIDERED, IT WAS DECIDED NOT TO USE FURTHER THROMBOLYTIC DRUGS BECAUSE OF THE RISK OF INTRACRANIAL HEMORRHAGE. EXPECTING TO CAPTURE THE RESIDUAL THROMBUS WITHIN THE STENT, IT WAS RESHEATHED AND REMOVED. CONTROL ANGIOGRAPHY THEN SHOWED COMPLETE REPERFUSION OF THE RIGHT MCA TERRITORY. THE PATIENT IMPROVED RECOVERING MOTION AND STRENGTH IN BOTH UPPER AND LOWER EXTREMITIES IMMEDIATELY AFTER THE PROCEDURE WITH SUBSEQUENT IMPROVEMENT TO A NIH STROKE SCORE OF 4. NO HEMORRHAGE WAS SEEN AND THERE WAS GOOD PATENCY OF THE MCA. THE DISCHARGE NIH STOKE SCORE WAS 0. THE RECAPTURED ENTERPRISE VRD IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE FURTHER ANALYSIS AND DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. AS OUTLINED IN THE INSTRUCTIONS FOR USE AND AS ACKNOWLEDGED BY THE AUTHORS, THE ENTERPRISE VRD IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS ARISING FROM A PARENT VESSEL WITH A DIAMETER OF 2.5MM AND 4MM. WIDE NECK IS DEFINED AS HAVING A NECK WIDTH 4MM OR A DOME-TO-NECK RATION <2. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THE AUTHORS REPORT THAT ONE OF THE MAJOR CONCERNS REGARDING THIS USE OF THE STENT IS IN-STENT THROMBOSIS DUE TO THE LACK OF ANTIPLATELET PREMEDICATION. ALTHOUGH IT WAS CONSIDERED BUT NOT USED IN THIS CASE, THE PATIENT INITIALLY ONLY RECEIVED UROKINASE AND NOT THE GPIIB/IIIA ANTAGONIST. IT WAS REPORTED THAT THE GPIIB/IIIA ANTAGONIST MAY BE ESSENTIAL IN STENT PLACEMENT FOR THE RECANALIZATION OF AN ACUTE STROKE WITH LACK OF ANTIPLATELET PREMEDICATION. THE ENTERPRISE IFU PRECAUTIONS THAT THE USE OF THE ENTERPRISE VRD IN PATIENTS IN WHOM ANTIPLATELET AND/OR ANTICOAGULANT THERAPY IS CONTRAINDICATED COULD RESULT IN A HIGHER RISK OF THROMBOSIS. ADDITIONAL DOSE OF INTRA-ARTERIAL UROKINASE WAS APPLIED TO DISSOLVE THE RESIDUAL THROMBUS CAPTURED BY THE STRUTS OF THE PARTIALLY DEPLOYED STENT. IT WAS FURTHER REPORTED THAT THE CAUSE OF RE-OCCLUSION OF THE RIGHT MCA WAS MOST LIKELY MIGRATION OF PARTIALLY DISSOLVED THROMBI WITHIN THE STENT STRUTS OR, LESS LIKELY, THE DEVELOPMENT OF ACUTE IN-STENT THROMBOSIS. PATIENT FACTORS AND PROCEDURAL FACTORS INCLUDING OFF LABEL USE, THE PRESENCE OF PRE-EXISTING THROMBUS, AND PARTIAL STENT DEPLOYMENT IN THE VESSEL APPEAR TO HAVE IMPACTED THE EVENT. BASED ON THE REPORTED PROCEDURAL INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS PUBLISHED IN THE AMERICAN JOURNAL OF NEURORADIOLOGY 2010 MAR;31(3):459-63. IN "SELF-EXPANDING STENT FOR RECANALIZATION OF ACUTE EMBOLIC OR DISSECTING INTRACRANIAL ARTERY OCCLUSION", S.H. SUH, ET AL., OFF-LABEL PARTIAL DEPLOYMENT OF AN ENTERPRISE STENT WAS USED SUCCESSFULLY AS THE INITIAL MECHANICAL MANEUVER FOR THE RECANALIZATION OF AN ACUTELY OCCLUDED VESSEL. THE PATIENT HAD ONLY RECEIVED UROKINASE WITHOUT GP IIA/IIIA ANTAGONIST AND AN ACUTE IN-STENT THROMBOSIS WAS REVEALED 10-20 MINUTES AFTER INITIAL RECANALIZATION. THE RE-OCCLUDED ARTERY WAS REOPENED BY RECAPTURE OF THE STENT. AT BASELINE THE PATIENT PRESENTED WITH ACUTE EMBOLIC OCCLUSIVE STROKE. THE PATIENT HAD A CONCOMITANT ACUTE TANDEM OCCLUSION OF THE IPSILATERAL CERVICAL INTERNAL CAROTID ARTERY (ICA) BULB AND MIDDLE CEREBRAL ARTERY (MCA); THEREFORE THE CAUSE OF THE MCA OCCLUSION WAS JUDGED TO BE AN ARTERY-TO-ARTERY EMBOLISM. NIH STROKE SCORE WAS 15 WITH TIMI 0.

    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 69 YR Required Intervention