BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2082205 · Received May 9, 2011

    Report

    Report Number
    1058196-2011-00213
    Event Type
    Death
    Date Received
    May 9, 2011
    Date of Event
    January 2, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: CORDIS LOT # 1427236 IS(B)(4) LOT #01427236. PER (B)(4) REPORT (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427236. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4) MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED 50 UNITS, WHICH WERE SHIPPED FROM (B)(4) MEDICAL ON (B)(4), 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE ENTERPRISE WAS 01427236. MEDICATIONS GIVEN CONSISTED OF HEPARIN 5000 UNITS, TPA 16MG, REOPRO 7MG, VERAPAMIL 20MG, AND OMNIPAGUE 370 77.6MG. THE PRE-PROCEDURE TIMI FLOW WAS 0 AND AFTER THE PROCEDURE WAS 2. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED THAT POST OFF-LABEL USE OF THE ENTERPRISE VRD FOR EMERGENCY STROKE TREATMENT THE PATIENT DIED. THROMBECTOMY, THROMBOLYSIS AND ENTERPRISE STENT RECONSTRUCTION WAS PERFORMED FOR EMERGENCY STOKE TREATMENT OF AN ACUTE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY (RICA) AND MIDDLE CEREBRAL ARTERY (MCA). IT WAS REPORTED THAT GOOD ANGIOGRAPHIC RESULTS WERE ACHIEVED WITH SUCCESSFUL REVASCULARIZATION OF THE RIGHT ICA AND RIGHT M1 WITH PARTIAL M2 OCCLUSIONS. HOWEVER WHEN RECOVERING IN THE ICU THE PATIENT WAS INITIALLY DOING VERY WELL AND THEN WAS FOUND TO HAVE A "CHANGE" IN CT SCAN DUE TO A VERY LARGE STROKE. AFTER EXTENSIVE DISCUSSION WITH THE FAMILY, IT WAS DETERMINED TO WITHDRAW CARE IN ORDER TO BE WITHIN THE PATIENT'S WISHES. THE PATIENT WAS EXTUBATED AND PALLIATIVE CARE MEASURES WERE INSTITUTED. THE PATIENT EXPIRED FOUR DAYS POST PROCEDURE. THE PATIENT HAD INITIALLY PRESENTED TO ANOTHER FACILITY AT 1.5 HOURS FROM THE ONSET OF LEFT FACIAL DROOP. TPA WAS ADMINISTERED AND UPON TRANSFER TO ANOTHER FACILITY FOR FURTHER CARE, SHE HAD A VERY POOR NEUROLOGICAL EXAM ON ARRIVAL. ANGIOGRAPHY DEMONSTRATED AN OCCLUDED RIGHT INTERNAL CAROTID ARTERY. HEPARIN WAS ADMINISTERED AND A PENUMBRA 054 ASPIRATION CATHETER WITH SEPARATOR WERE USED TO PERFORM THROMBECTOMY OF THE RIGHT CERVICAL ICA. AFTER MULTIPLE TIMES, THROMBECTOMY OF THE ICA TO THE PCOM WAS PERFORMED SUCCESSFULLY. THERE WAS A HARD BLOCKAGE OF THE SUPRACLINOID CAROTID DISTAL TO THE PCOM. A 026 PENUMBRA ASPIRATION CATHETER OVER A TRANSCEND WIRE WAS USED TO ATTEMPT TO NAVIGATE PAST THE OCCLUSION WITHOUT SUCCESS AND THE CATHETER WAS REMOVED. AN SL-10 OVER A TRANSCEND WIRE WAS NAVIGATED ACROSS THE LESION. THE WIRE WAS REMOVED AND 3MG OF TPA WAS ADMINISTERED INTO THE RIGHT M1 MCA AND THEN AN EXCHANGE LENGTH 014 WIRE WAS PLACED IN THE RIGHT MCA. ANGIOPLASTY WAS THEN PERFORMED USING A 2.5X15MM APEX BALLOON FOLLOWED BY UNSUCCESSFUL NAVIGATION OF A 3.5MMX12MM APEX BALLOON ACROSS THE STENOSIS. ANGIOPLASTY WITH THE 2.5MMX15MM WAS THEN PERFORMED AGAIN. THE RIGHT ICA WAS PATENT WITH POOR FLOW ACROSS THE DISTAL ICA WHICH HAD THROMBUS AND LIKELY UNDERLYING ATHEROSCLEROTIC DISEASE. AFTER REMOVAL OF THIS BALLOON, A PROWLER SELECT PLUS WAS PLACED IN THE RIGHT MCA AND THE 28MM ENTERPRISE VRD WAS DEPLOYED AC4ROSS THE LESION. A 7MG OF TPA WAS THEN ADMINISTERED INTO THE RIGHT ICA. THE PROWLER WAS ADVANCED UP OVER THE WIRE THROUGH THE STENT LUMEN, THE DELIVERY WIRE WAS REMOVED, AND THEN AN EXCHANGE LENGTH 014 WIRE WAS PLACED IN THE MCA AND THE PROWLER WAS REMOVED. 5MG OF REOPRO WAS ADMINISTERED IN THE RIGHT ICA. POST STENTING ANGIOGRAPHY DESCRIPTION WAS UNCHANGED. A 2.5MMX8MM APEX BALLOON WAS THEN PLACED THROUGH THE STENT AND ANGIOPLASTY WAS PERFORMED. VIA AN SL-10 PLACED INTO THE RIGHT MCA 6MG OF TPA AND 1MG OF REOPRO WAS ADMINISTERED. WIRE MACERATION OF THE M2 AND M3 OCCLUSIONS WERE PERFORMED. FINAL ANGIOGRAPHY WAS PERFORMED WHICH SHOWED THE RIGHT ICA WAS PATENT WITH POOR LOW ACROSS THE DISTAL ICA WHICH HAD THROMBUS AND LIKELY UNDERLYING ATHEROSCLEROTIC DISEASE. THERE WAS DIFFUSE CLOT IN ALL THE DISTAL M2 AND M3 VESSELS. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE SPECIFICS OF THE CHANGES SEEN WITH CT SCAN. NOTE: CORDIS LOT # 1427236 IS LAKE REGION LOT #01427236. PER LAKE REGION REPORT (B)(4) - LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427236. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED 50 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON OCTOBER 1, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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. ADDITIONALLY, IT WARNS THAT THE ABILITY OF THE STENT TO WITHSTAND POST BALLOON DILATATION HAS NOT BEEN ESTABLISHED. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. 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 POST PROCEDURE CT SCAN INDICATING A LARGE STROKE. PROCEDURAL FACTORS AND THE PATIENT'S PRE-PROCEDURE PRESENTATION, AND MEDICAL HISTORY ARE FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONTINUE: 8F SHEATH; 6F KSAW CATHETER; H1 SLIPCATH; 0.035 G/W; PENUMBRA .054 ASPIRATION CATHETER; APEX BALLOON 2.5 X 15MM & 3.5 X 12MM; PROWLER SELECT PLUS. HEPARIN WAS ADMINISTERED AND A PENUMBRA 054 ASPIRATION CATHETER WITH SEPARATOR WERE USED TO PERFORM THROMBECTOMY OF THE RIGHT CERVICAL ICA. AFTER MULTIPLE TIMES, THROMBECTOMY OF THE ICA TO THE PCOM WAS PERFORMED SUCCESSFULLY. THERE WAS A HARD BLOCKAGE OF THE SUPRACLINOID CAROTID DISTAL TO THE PCOM. A 026 PENUMBRA ASPIRATION CATHETER OVER A TRANSCEND WIRE WAS USED TO ATTEMPT TO NAVIGATE PAST THE OCCLUSION WITHOUT SUCCESS AND THE CATHETER WAS REMOVED. AN SL-10 OVER A TRANSCEND WIRE WAS NAVIGATED ACROSS THE LESION. THE WIRE WAS REMOVED AND 3MG OF TPA WAS ADMINISTERED INTO THE RIGHT M1 MCA AND THEN AN EXCHANGE LENGTH 014 WIRE WAS PLACED IN THE RIGHT MCA. ANGIOPLASTY WAS THEN PERFORMED USING A 2.5X15MM APEX BALLOON FOLLOWED BY UNSUCCESSFUL NAVIGATION OF A 3.5MMX12MM APEX BALLOON ACROSS THE STENOSIS. 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. ADDITIONALLY IT WARNS THAT THE ABILITY OF THE STENT TO WITHSTAND POST BALLOON DILATATION HAS NOT BEEN ESTABLISHED. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. 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 POST PROCEDURE CT SCAN INDICATING A LARGE STROKE. PROCEDURAL FACTORS AND THE PATIENT'S PRE-PROCEDURE PRESENTATION, AND MEDICAL HISTORY ARE FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT POST OFF-LABEL USE OF THE ENTERPRISE VRD FOR EMERGENCY STROKE TREATMENT THE PATIENT DIED. THROMBECTOMY, THROMBOLYSIS AND ENTERPRISE STENT RECONSTRUCTION WAS PERFORMED FOR EMERGENCY STOKE TREATMENT OF AN ACUTE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY (RICA) AND MIDDLE CEREBRAL ARTERY (MCA). IT WAS REPORTED THAT GOOD ANGIOGRAPHIC RESULTS WERE ACHIEVED WITH SUCCESSFUL REVASCULARIZATION OF THE RIGHT ICA AND RIGHT M1 WITH PARTIAL M2 OCCLUSIONS. HOWEVER WHEN RECOVERING IN THE ICU THE PATIENT WAS INITIALLY DOING VERY WELL AND THEN WAS FOUND TO HAVE A "CHANGE" IN CT SCAN DUE TO A VERY LARGE STROKE. AFTER EXTENSIVE DISCUSSION WITH THE FAMILY IT WAS DETERMINED TO WITHDRAW CARE IN ORDER TO BE WITHIN THE PATIENT'S WISHES. THE PATIENT WAS EXTUBATED AND PALLIATIVE CARE MEASURES WERE INSTITUTED. THE PATIENT EXPIRED FOUR DAYS POST PROCEDURE. THE PATIENT HAD INITIALLY PRESENTED TO ANOTHER FACILITY AT 1.5 HOURS FROM THE ONSET OF LEFT FACIAL DROOP. TPA WAS ADMINISTERED AND UPON TRANSFER TO ANOTHER FACILITY FOR FURTHER CARE SHE HAD A VERY POOR NEUROLOGICAL EXAM ON ARRIVAL. ANGIOGRAPHY DEMONSTRATED AN OCCLUDED RIGHT INTERNAL CAROTID ARTERY.

    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 01427236

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death