BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1981153 · Received February 8, 2011

    Report

    Report Number
    1058196-2011-00055
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 8, 2010
    Report Date
    February 1, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODIFIED RANKIN SCALE AT TIME OF THE EVENT WAS 4. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ESAT STUDY INDICATED THAT PATIENT WITH ID 2-28 EXPERIENCED (MCA) MIDDLE CEREBRAL STOKE DUE TO INTRA-STENT THROMBOSIS TEN DAYS AFTER THE INDEX PROCEDURE, ALTHOUGH A GOOD RESPONSE WITH PLAVIX WAS VERIFIED. THE PATIENT HAD A PREVIOUS STROKE IN THE SAME TERRITORY, SO THROMBOEMBOLIC EVENT IS SUSPECTED. THE MRS WAS 4 AT THE TIME OF THE EVENT. DURING THE EVENT, THE PATIENT HAD NEUROLOGICAL SYMPTOMS/DEFICITS CONSISTING OF A GLASGOW SCALE 15 - LEFT HEMIPLEGIA "PARALYSIS OF THE LEFT FACE" SPASMS OF THE LEFT INFERIOR LIMB. ON INITIAL ANGIOGRAMS, THE TARGET SITE WAS NOT OCCLUDED OR STENOTIC. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE VESSEL AND STENTED AREA WAS PATENT. THE VESSEL SIZE PROXIMALLY WAS 2.8MM AND DISTALLY WAS 2.7MM. THE ENTERPRISE WAS FULLY EXPANDED AND OPPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT. DURING THE EVENT, ANGIOGRAMS WERE PERFORMED DURING THE EVENT THAT SHOWED THAT THE ENTERPRISE WAS FULLY EXPANDED, OPPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. ADDITIONALLY, THE FOLLOW-UP ANGIOGRAM DID NOT REVEALED ANY FACTORS WITH THE DEVICE OR VESSEL THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE INDEX PROCEDURE, THE PATIENT UNDERWENT COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE STENT (ENC451412/01425064) OF THE RIGHT MIDDLE CEREBRAL SIDEWALL NON-RUPTURED ANEURYSM THAT MEASURE 8.5MM SAC HEIGHT, SAC WIDTH OF 6.8MM AND THE NECK WAS 4.5MM. THE WFNS AND (MRS) MODIFIED RANKIN SCALE WERE BOTH 0. AN ENTERPRISE 14MM WAS PLACED AT THE SITE, AND JAILED TECHNIQUE WAS UTILIZED DURING THE PROCEDURE. NO BALLOON WAS UTILIZED. AFTER THE PROCEDURE, TREATMENT WAS ACHIEVED WITHOUT ADVERSE EVENTS, BUT THERE WAS RESIDUAL ANEURYSM. MEDICATIONS GIVEN CONSISTED OF ASPIRIN PRE AND POST PROCEDURE, ANTIPLATELET POST-PROCEDURE, AND HEPARIN INTRA-PROCEDURE. THE WFNS AND MRS WERE BOTH 0 AT DISCHARGED. MEDICATIONS CONSISTED OF HEPARIN PER PROCEDURE, PLAVIX 71MG/DAY AND ASPEGIC 250MG/DAY. THE PATIENT WAS DISCHARGED FIVE DAYS AFTER PROCEDURE. APPROXIMATELY 12 DAYS AFTER THE INDEX PROCEDURE, COMPLETED IRM EXAM CONCLUDED OCCLUSION OF THE MCA PROXIMAL RIGHT, AND ISCHEMIA EXTENDING INTO THE RIGHT FRONTO-TEMPORAL. A DAY AFTER THIS REPORT, ANGIOGRAPHY EXAM CONFIRMED STENT OCCLUSION, TAKE IN CHARGE OF THE CEREBRAL PARENCHYMA BY ANASTOMOSIS OF THE ANTERIOR CEREBRAL ARTERY. FINALLY, TWO WEEKS AFTER THE INDEX PROCEDURE THE PATIENT HAD MEMORY IMPAIRMENT DUE TO ALCOHOL WITHDRAWAL APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT STILL HAD LEFT HEMIPLEGIC. SMALL ACTIVITY RECORDED OF THE LEFT HIP AND LEFT KNEE EXTENSORS MUSCLES. PATIENT IS IN REEDUCATION UNIT. (B)(4) 2010 : INR 1.3% . (B)(4) 2010 : COOMB TEST NEGATIVE. (B)(4) 2010 INR=1.1%. THE MEDICAL HISTORY CONSISTED OF ACTIVE SMOKER, ALCHOLEMIA, ARTERIAL HYPER TENSION (4 THERAPIES), DYSLIPIDEMIA, DEPRESSIVE SYNDROME, PREVIOUS STROKES, BUT NO HISTORY OF SUB-ARACHNOID HEMORRHAGE, AND THE PATIENT NON-COMPLIANT WITH PLAVIX. CURRENT MEDICATIONS CONSISTED OF VASTAREL 35MG (2/DAY), CELECTOL 200 (1/DAY), APPROVEL 150 (1/DAY), LERCAN 10 (1/2/DAY), ZOLOFT 50 (1/DAY), XANAX (1/DAY), ZOLPIDEN, AND GAVISCON. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY (B)(4) THAT ALTHOUGH A GOOD RESPONSE WITH PLAVIX WAS VERIFIED, THE PATIENT EXPERIENCED A MIDDLE CEREBRAL ARTERY (MCA) STROKE DUE TO AN INTRA-STENT THROMBOSIS TEN DAYS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS SERIOUS MEDICAL HISTORY OF ALCOHOLEMIA, AND THE INVESTIGATOR SUSPECTED THAT PATIENT NOT RESPECTED HIS TREATMENT WITH PLAVIX. AT BASELINE, THE PATIENT HAD A WFNS AND (MRS) MODIFIED RANKIN SCALE SCORE OF 0. DURING THE INDEX PROCEDURE, THE PATIENT UNDERWENT COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE STENT OF THE RIGHT MIDDLE CEREBRAL SIDEWALL NON-RUPTURED ANEURYSM WITH AN 8.5MM SAC HEIGHT, SAC WIDTH OF 6.8MM AND THE NECK WAS 4.5MM. THE PARENT VESSEL PROXIMAL TO THE ANEURYSM WAS 2.8MM AND DISTALLY WAS 2.7MM. ON INITIAL ANGIOGRAM, THE TARGET SITE WAS NOT OCCLUDED OR STENOTIC AND NO THROMBUS WAS OBSERVED. THE ENTERPRISE 14MM WAS PLACED AT THE SITE. THE ENTERPRISE STENT WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT. A JAILED MICROCATHETER TECHNIQUE FOR DELIVERY OF COILS WAS UTILIZED DURING THE PROCEDURE. NO BALLOON WAS UTILIZED. AFTER THE PROCEDURE, TREATMENT WAS ACHIEVED WITHOUT ADVERSE EVENTS. IT WAS INDICATED THAT THERE WAS RESIDUAL ANEURYSM. AFTER STENT PLACEMENT AND COIL EMBOLIZATION, THE VESSEL/STENTED AREA WAS PATENT. MEDICATIONS GIVEN CONSISTED OF ASPIRIN PRE AND POST PROCEDURE, ANTIPLATELET POST-PROCEDURE, AND HEPARIN INTRA-PROCEDURE. THE WFNS AND MRS WERE BOTH 0 AT POST PROCEDURE DISCHARGE. THE MRS WAS 4 AT THE TIME OF THE EVENT WITH LEFT HEMIPLEGIA, PARALYSIS OF THE LEFT FACE, AND SPASMS OF THE LEFT INFERIOR LIMB. THE PATIENT HAD A PREVIOUS STROKE IN THE SAME TERRITORY, SO THROMBOEMBOLIC EVENT IS SUSPECTED. MAGNETIC RESONANCE IMAGING ELEVEN DAYS POST PROCEDURE DEMONSTRATED COMPLETE OCCLUSION OF THE PROXIMAL RIGHT MCA WITH ISCHEMIA EXTENDED TO THE RIGHT FRONTAL-TEMPORAL AREA. ANGIOGRAPHY CONFIRMED STENT OCCLUSION WITH FLOW TO THE CEREBRAL PARENCHYMA VIA ANASTOMOSIS OF THE ANTERIOR CEREBRAL ARTERY. THE FOLLOW-UP ANGIOGRAM DID NOT SHOW OR REVEAL ANY FACTORS WITH THE DEVICE OR VESSEL THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE ENTERPRISE WAS FULLY EXPANDED, OPPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD MEMORY IMPAIRMENT DUE TO ALCOHOL WITHDRAWAL. THREE MONTHS LATER, THE PATIENT REMAINS WITH LEFT HEMIPLEGIA WITH SMALL ACTIVITY RECORDED OF THE LEFT HIP AND LEFT KNEE EXTENSOR MUSCLES. THE PATIENT IS IN A RE-EDUCATION UNIT. ADDITIONAL MEDICAL HISTORY WAS REPORTED AS: ACTIVE SMOKER, ALCOHOLEMIA, ARTERIAL HYPER TENSION (4 THERAPIES), DYSLIPIDEMIA, DEPRESSIVE SYNDROME, PREVIOUS STROKES, BUT NO HISTORY OF SUB-ARACHNOID HEMORRHAGE, AND NON-COMPLIANT WITH PLAVIX. THE STENT REMAINS IMPLANTED; THEREFORE, IS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425064. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. STENT THROMBOSIS AND STROKE ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION, THE PATIENT'S MEDICAL HISTORY OF PREVIOUS STROKE IN THE SAME TERRITORY AND REPORTED POSSIBLE NONCOMPLIANCE WITH ANTIPLATELET THERAPY ARE IDENTIFIED FACTORS POSSIBLY CONTRIBUTING TO THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORDS REVIEW, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE (B)(4) STUDY INDICATED THAT PATIENT WITH ID (B)(4) EXPERIENCED (MCA) MIDDLE CEREBRAL STOKE DUE TO INTRA-STENT THROMBOSIS TEN DAYS AFTER THE INDEX PROCEDURE, ALTHOUGH A GOOD RESPONSE WITH PLAVIX WAS VERIFIED. THE PATIENT HAD A PREVIOUS STROKE IN THE SAME TERRITORY, SO THROMBOEMBOLIC EVENT IS SUSPECTED. DURING THE INDEX PROCEDURE, THE PATIENT UNDERWENT COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE STENT OF THE RIGHT MIDDLE CEREBRAL SIDEWALL NON-RUPTURED ANEURYSM THAT MEASURE 8.5MM SAC HEIGHT, SAC WIDTH OF 6.8MM AND THE NECK WAS 4.5MM. THE WFNS AND (MRS) MODIFIED RANKIN SCALE WERE BOTH 0. AN ENTERPRISE 14MM WAS PLACED AT THE SITE, AND JAILED TECHNIQUE WAS UTILIZED DURING THE PROCEDURE. NO BALLOON WAS UTILIZED. AFTER THE PROCEDURE, TREATMENT WAS ACHIEVED WITHOUT ADVERSE EVENTS, BUT THERE WAS RESIDUAL ANEURYSM. MEDICATIONS GIVEN CONSISTED OF ASPIRIN PRE AND POST PROCEDURE, ANTIPLATELET POST-PROCEDURE, AND HEPARIN INTRA-PROCEDURE. THE WFNS AND MRS WERE BOTH 0 AT DISCHARGED.

    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 01425064

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening