BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2439110 · Received February 6, 2012

    Report

    Report Number
    1058196-2012-00059
    Event Type
    Death
    Date Received
    February 6, 2012
    Date of Event
    May 14, 2011
    Report Date
    January 25, 2012
    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

    PLEASE NOTE THAT "NO INFORMATION" WAS USED BECAUSE THERE IS NO CODE AVAILABLE FOR DEVICE INEFFECTIVE. THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA THE (B)(4) ENTERPRISE POST MARKET CLINICAL STUDY THAT THE DAY AFTER PRESENTING WITH A SUBARACHNOID HEMORRHAGE, THE PATIENT UNDERWENT ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF A LEFT POSTERIOR CEREBRAL ARTERY ANEURYSM. ONE DAY POST PROCEDURE, CT REVEALED BRAIN-STEM HEMORRHAGE AND A GROWING SUBARACHNOID HEMORRHAGE. NO ACTION WAS TAKEN AND THE PATIENT DIED FIVE DAYS POST INDEX PROCEDURE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNKNOWN AND TO THE VRD WAS HIGHLY UNLIKELY UNRELATED; HOWEVER, THE EXACT SOURCE OF BLEEDING WAS UNKNOWN. AT INDEX PROCEDURE, THE RUPTURED FUSIFORM ANEURYSM NECK WAS 4.1MM, AND THE NECK TO SAC RATIO WAS 4.1MM: 4.1MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.5MM AND DISTALLY WAS 2.5MM. THE PATIENT'S NEUROLOGICAL STATUS PRIOR TO THE PROCEDURE AND IMMEDIATELY POST PROCEDURE ARE NOT KNOWN. PRIOR TO IMPLANTING THE ENTERPRISE VIA A PROWLER SELECT PLUS, A SLIMGUIDE/MEDIKIT AND CHIKAI/ASAHI INTECC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10, CHIKAI/ASAHI INTECC, AND A TOTAL OF 5 ED COILS/KANEKA. HEPARIN 5000 UNITS WAS ADMINISTERED INTRA-PROCEDURALLY; ACT WAS NOT MEASURED. THE POST PROCEDURE ANEURYSM OCCLUSION RATE WAS 80%. ANTIPLATELET THERAPY INCLUDED ASPIRIN 300MG/DAY, CLOPIDOGREL 150MG/DAY, AND CILOSTAZOL 200MG/DAY ON THE INDEX PROCEDURE DAY. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. LR PACKAGING L/N # (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 01424845. 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. THE INSTRUCTIONS FOR USE OUTLINES THAT HEMORRHAGE IS A KNOWN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM IN THE INTRACRANIAL ARTERIES. IT WAS REPORTED BY THE PHYSICIAN THAT THE EVENTS ARE HIGHLY UNLIKELY RELATED TO THE ENTERPRISE VRD; HOWEVER, BASED ON THE LIMITED AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE. PROCEDURAL FACTORS AND THE PATIENT'S SIGNIFICANT MEDICAL HISTORY/PRESENTATION MAY HAVE CONTRIBUTED. WITH REVIEW OF THE LIMITED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT FROM THE CLINICAL STUDY (B)(4) FOR PATIENT WITH (B)(6) INDICATED THAT DAY PRIOR TO THE PROCEDURE, THE PATIENT WAS ADMITTED WITH SUBARACHNOID HEMORRHAGE AND UNDERWENT A COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN (B)(4) AND NON-CORDIS/CODMAN COILS OF THE LEFT POSTERIOR CEREBRAL ARTERY, AND ONE DAY AFTER THE INDEX PROCEDURE, CT REVEALED THE BRAIN-STEM HEMORRHAGE AND THE GROWING SUBARACHNOID HEMORRHAGE. NO ACTION WAS TAKEN. THE PATIENT DIED FIVE DAYS AFTER THE INDEX PROCEDURE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNKNOWN AND TO THE VRD WAS UNRELATED. THE EXACT SOURCE OF BLEEDING WAS UNKNOWN. THE BRAIN-STEM HEMORRHAGE AND THE GROWING SUBARACHNOID HEMORRHAGE WAS LOCATED IN THE SAME AREA THAT WAS TREATED WITH THE VRD, BUT (B)(4) WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE RUPTURED FUSIFORM ANEURYSM NECK WAS 4.1MM, AND THE NECK TO SAC RATIO WAS 4.1MM: 4.1MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.5MM AND DISTALLY WAS 2.5MM. ANTIPLATELET THERAPY INCLUDED ASPIRIN 300MG/DAY: 2011 (B)(6), CLOPIDOGREL SULFATE 150MG/DAY: 2011 (B)(6), CILOSTAZOL 200MG/DAY: 2011 (B)(6). HEPARIN 5000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE OCCLUSION RATE OF ANEURYSM WAS 80% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, SLIMGUIDE/MEDIKIT, (B)(4) (LOT#UNKOWN), (B)(4) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, (B)(4).

    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 01424845

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death COILS