BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2212468 · Received August 16, 2011

    Report

    Report Number
    1058196-2011-00411
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    April 14, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE, AND THE STENT WAS NOT IMPLANTED WITHIN THROMBUS. THE OCCLUSION RATE OF ANEURYSMS WAS 90% AFTER THE PROCEDURE. DEVICES UTILIZED DURING THE PROCEDURE CONSISTED OF ROADMASTER/ GOODMAN GUIDING CATHETER, PROWLER SELECT PLUS MICROCATHETER (B)(4), EXCELSIOR 1018 MICROCATHETER ( BOSTON SCIENTIFIC), CHIKAI / ASAHI INTECC GUIDEWIRE, RADIFOCUS GT/ TERUMO, CASHMERE/ MICRUS COILS (TOTAL 14), PRESIDIO/ MICRUS COILS (TOTAL 4). THE ANTIPLATELET THERAPY CONSISTED OF CILOSTAZOL 200MG/DAY: 2011 (B)(6), ASPIRIN 100MG/DAY: 2011 (B)(6) ~2011 (B)(6), CLOPIDOGREL SULFATE 150MG/DAY: 2011 (B)(6) ~2011 (B)(6), CLOPIDOGREL SULFATE 75MG/DAY: 2011 (B)(6), AND HEPARIN 18,000U: 2011 (B)(6) (DURING THE PROCEDURE). THE SACCULAR UNRUPTURED ANEURYSM MEASUREMENT WAS NECK 9.8MM AND NECK TO SAC RATION WAS 9.8MM/16.1MM, AND THE PARENT VESSEL SIZE/DIAMETER PROXIMALLY WAS 4.3MM AND DISTALLY WAS 3.1MM. THE PATIENT'S MEDICAL HISTORY CONSISTED OF COIL EMBOLIZATION FOR LEFT INTERNAL CAROTID ANEURYSM AND LEFT MIDDLE CEREBRAL ARTERY ANEURYSM. A CD COPY OF THE PROCEDURE OR FURTHER INFORMATION WAS NOT AVAILABLE. (B)(4). PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424663. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4) AND (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. CEREBRAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH NEUROVASCULAR STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF CEREBRAL STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL INTO THE DOWNSTREAM FLOW OR VESSEL SPASM IN REACTION TO THE INTRODUCTION OF THE DEVICES THAT MAY SLOW OR COMPLETELY OCCLUDE THE BLOOD FLOW. THE INTRODUCTION OF INTERVENTIONAL DEVICES AND STENT IMPLANTATION MAY LEAD TO A SLOWING OR STOPPAGE OF BLOOD FLOW TO THE DOWNSTREAM VESSELS AND STRUCTURES OF THE BRAIN CAUSING INFARCTIONS OF THESE STRUCTURES. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE (B)(4) STUDY INDICATED THAT 16 HOURS AFTER AN ENTERPRISE VRD ASSISTED BASILAR ARTERY TRUNK ANEURYSM COILING PROCEDURE THE PATIENT DEVELOPED MILD WEAKNESS IN LEFT INFERIOR LIMB AND ASYMPTOMATIC CEREBRAL INFARCTION IN RIGHT OCCIPITAL LOBE. DURING THE EVENT, THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO THE INITIAL POSITION AFTER PLACEMENT. THE PATIENT WAS TREATED WITH EDARAVONE. THE EVENT OUTCOME OF THE WEAKNESS IN LEFT INFERIOR LIMB RESOLVED THREE DAYS AFTER AND THE ASYMPTOMATIC CEREBRAL INFARCTION IN RIGHT OCCIPITAL LOBE RESOLVED APPROXIMATELY A MONTHS AFTER ONSET. ADDITIONAL INFORMATION HAS BEEN RECEIVED REPORTING THAT EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD EPISODES OF OCCLUSION OF BASILAR ARTERY THAT CAUSED WIDE-SPREAD INFARCTION OF THE BRAINSTEM AND CEREBELLUM. ACTION TAKEN WAS LOCAL THROMBOLYSIS. HOWEVER, DESPITE THE TREATMENTS, THE PATIENT DIED TWO WEEKS AFTER ONSET. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED WHEREAS TO THE DEVICE WAS HIGHLY PROBABLE. THE POSSIBLE CAUSE OF THE EVENT WAS BECAUSE THE PATIENT MIGHT HAVE NOT BEEN ADMINISTRATED THE SUFFICIENT DOSAGES OF ANTIPLATELET AGENTS. NO FURTHER INFORMATION REGARDING THIS EVENT IS AVAILABLE. AFTER INDEX STENT ASSISTED COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE. THE SACCULAR UNRUPTURED ANEURYSM MEASUREMENT WAS NECK 9.8 MM AND NECK TO SAC RATION WAS 9.8 MM/16.1 MM, AND THE PARENT VESSEL SIZE/DIAMETER PROXIMALLY WAS 4.3 MM AND DISTALLY WAS 3.1 MM. THE RECOMMENDED PARENT VESSEL UPPER LIMIT DIAMETER FOR PLACEMENT OF THE ENTERPRISE VRD AS OUTLINED IN THE IFU IS 4.0 MM. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THE MODIFIED RANKIN SCALE (MRS) SCORE BEFORE THE PROCEDURE WAS 2, AND 1 MONTH AFTER THE PROCEDURE WAS 2. HEPARIN 18,000U WAS ADMINISTERED DURING THE PROCEDURE. THE ACT PREP-PROCEDURE WAS 147 SECONDS AND POST-ANTICOAGULATION WAS 312 SECONDS. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE, AND THE STENT WAS NOT IMPLANTED WITHIN THROMBUS. THE OCCLUSION RATE OF ANEURYSMS WAS 90% AFTER THE PROCEDURE. THE PRESCRIBED ANTIPLATELET THERAPY CONSISTED OF CILOSTAZOL 200MG/DAY BEGINNING 18 DAYS BEFORE THE INDEX PROCEDURE AND THEN 150 MG/DAY THE DAY BEFORE AND THE DAY OF THE PROCEDURE FOLLOWED BY 75 MG/DAY BEGINNING ONE DAY POST PROCEDURE. ASPIRIN 100 MG/DAY WAS PRESCRIBED THE DAY BEFORE AND THE DAY OF THE PROCEDURE. THE PATIENT'S MEDICAL HISTORY CONSISTED OF COIL EMBOLIZATION FOR LEFT INTERNAL CAROTID ANEURYSM AND LEFT MIDDLE CEREBRAL ARTERY ANEURYSM. NO FURTHER INFORMATION IS AVAILABLE AND THERE ARE NO PROCEDURAL IMAGES OR IMAGES PERTAINING TO THE REPORTED EVENT AVAILABLE. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424663. 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. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. CEREBRAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH NEUROVASCULAR STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF CEREBRAL STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL INTO THE DOWNSTREAM FLOW OR VESSEL SPASM IN REACTION TO THE INTRODUCTION OF THE DEVICES THAT MAY SLOW OR COMPLETELY OCCLUDE THE BLOOD FLOW. THE INTRODUCTION OF INTERVENTIONAL DEVICES AND STENT IMPLANTATION MAY LEAD TO A SLOWING OR STOPPAGE OF BLOOD FLOW TO THE DOWNSTREAM VESSELS AND STRUCTURES OF THE BRAIN CAUSING INFARCTIONS OF THESE STRUCTURES. ADDITIONALLY, THROMBOTIC EVENTS ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE IFU. THE ENTERPRISE WAS IMPLANTED IN A PARENT VESSEL WHOSE DIAMETER WAS GREATER THAN THE MAXIMUM DIAMETER OF 4.0 MM AS SITED IN THE IFU. ADDITIONALLY, AS REPORTED THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE PATIENT MIGHT HAVE NOT BEEN ADMINISTRATED THE SUFFICIENT DOSAGES OF ANTIPLATELET AGENTS. THIS INHERENT RISK OF THE PROCEDURE COMBINED WITH PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS AND SIZE GREATER THAN THE MAXIMUM DIAMETER OUTLINED IN THE IFU, THE PATIENT'S COMPLEX MEDICAL STATUS AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD EPISODES OF OCCLUSION OF BASILAR ARTERY THAT CAUSED WIDE-SPREAD INFARCTION OF THE BRAINSTEM AND CEREBELLUM. ACTION TAKEN WAS LOCAL THROMBOLYSIS. HOWEVER, DESPITE THE TREATMENTS, THE PATIENT DIED TWO WEEKS AFTER ONSET. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED WHEREAS TO THE DEVICE WAS HIGHLY PROBABLE. THE POSSIBLE CAUSE OF THE EVENT WAS BECAUSE THE PATIENT MIGHT HAVE NOT BEEN ADMINISTRATED THE SUFFICIENT DOSAGES OF ANTIPLATELET AGENTS. IT WAS NOTED THAT THE MRS ONE DAY BEFORE THE INDEX PROCEDURE WAS 2, THREE DAYS AFTER WAS 2 AND A MONTHS AFTER WAS 2. ONE YEAR FOLLOW UP WAS NOT CONDUCTED DUE TO THE DEATH OF THE PATIENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH (B)(6) INDICATED THAT THE UNDERWENT PATIENT COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE VRD (B)(4) FOR CEREBRAL ARTERY ANEURYSM IN BA-TRUNK, AND 16 HOURS AFTER THE PROCEDURE, THE PATIENT DEVELOPED MILD WEAKNESS IN LEFT INFERIOR LIMB AND ASYMPTOMATIC CEREBRAL INFARCTION IN RIGHT OCCIPITAL LOBE. THE PATIENT WAS TREATED WITH EDARAVONE. THE EVENT OUTCOME OF THE WEAKNESS IN LEFT INFERIOR LIMB RESOLVED THREE DAYS AFTER AND THE ASYMPTOMATIC CEREBRAL INFARCTION IN RIGHT OCCIPITAL LOBE RESOLVED APPROXIMATELY A MONTHS AFTER ONSET. ADDITIONALLY, FOUR DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED URINARY TRACT INFECTIONS AND WAS TREATED WITH ANTIBIOTICS, AND THE EVENT A RESOLVED AFTER WEEK. DURING THE EVENT, THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO THE INITIAL POSITION AFTER PLACEMENT. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE.

    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 01424663

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR