BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2083410 · Received May 10, 2011

    Report

    Report Number
    1058196-2011-00226
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: CORDIS LOT # 01424848 IS LAKE REGION LOT # 01424848. PER LAKE REGION REPORT (B)(4)- LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424848. 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. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(4), 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00225 & 1058196-2011-00226. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ONE NON STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE INTRODUCER TUBE WAS RECEIVED DETACHED OF THE DELIVERY WIRE (THE DELIVERY WIRE NOT INSERTED IN THE INTRODUCER); NEITHER THE DELIVERY WIRE NOR THE INTRODUCER TUBE PRESENTED ANY VISUAL DAMAGES. THE STENT WAS NOT RECEIVED FOR THE ANALYSIS. THE MICROCATHETER INVOLVED IN THE PROCEDURE WAS RECEIVED COILED INSIDE A PLASTIC BAG, UNDER (B)(4). IT PRESENTED FLAT CONDITION AT 8.1 CM FROM DISTAL END, KINKED CONDITIONS AT 0.5, 69.5, 98 AND 120 CM FROM DISTAL END AND BENT CONDITIONS AT 16.5, 26.2, 40.5 AND 67 CM FROM DISTAL END. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424848. 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. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(4), 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE BY CUSTOMER AS "STENT- KINKED/BENT" WAS NOT CONFIRMED DUE THE STENT WAS NO RECEIVED FOR ANALYSIS. THE REPORTED FAILURE BY CUSTOMER AS "DELIVERY WIRE- RESISTANCE/FRICTION" WAS CONFIRMED DUE TO DURING THE FUNCTIONAL TEST RESISTANCE AND FRICTION WAS FELT WHEN THE DELIVERY PASSED ON THE KINKED/BENT CONDITIONS UNTIL STOPPED IN A PRONOUNCED KINKED, THE CAUSE OF THESE DAMAGES COULD NOT BE DETERMINED CONCLUSIVELY, HOWEVER IT DOES NOT APPEARS TO BE MANUFACTURING RELATED OF THE PRODUCT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00225 & 1058196-2011-00226. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A STENT ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THERE WAS INABILITY TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE PROWLER SELECT PLUS 150/5 CM 45, AND AFTER REMOVAL IT WAS NOTED THAT PROXIMAL SHAFT OF THE MICROCATHETER WAS KINK, AS WELL AS THE ENTERPRISE STENT. THE REPORTED EVENT OCCURRED WHEN THE ENTERPRISE WAS BEING ADVANCED THROUGH THE MICROCATHETER AND IT IS UNKNOWN IF THERE WAS ANY RESISTANCE/FRICTION BETWEEN THE ENTERPRISE SYSTEM AND MICROCATHETER OR IF A GUIDEWIRE INSERTED TO EXCHANGE THE MICROCATHETER OR IF THE MICROCATHETER AND ENTERPRISE WERE REMOVED AS A UNIT. HOWEVER, THE SAME MICROCATHETER WAS NOT UTILIZED TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT RE-SHAPED, AND A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED OR FRACTURE, ETC), DISTAL TIP (UNRAVEL, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), STENT (FRACTURE, SEPARATED, ETC) OR MICROCATHETER (FRACTURE, SEPARATED, ETC). THE TARGET SITE WAS THE (P-COM) POSTERIOR COMMUNICATING ARTERY. ONE NON STERILE ENTERPRISE VRD DELIVERY SYSTEM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE INTRODUCER TUBE WAS RECEIVED SEPARATELY FROM THE DELIVERY WIRE (THE DELIVERY WIRE NOT INSERTED IN THE INTRODUCER); NEITHER THE DELIVERY WIRE NOR THE INTRODUCER TUBE PRESENTED ANY VISUAL DAMAGES. THE STENT WAS NOT RECEIVED FOR THE ANALYSIS. THE PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG, IT PRESENTED FLAT CONDITION AT 8.1 CM FROM DISTAL END, KINKED CONDITIONS AT 0.5, 69.5, 98 AND 120 CM FROM DISTAL END AND BENT CONDITIONS AT 16.5, 26.2, 40.5 AND 67 CM FROM DISTAL END. THE RECEIVED MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE; AFTER THAT A LAB SAMPLE CORDIS GUIDE WIRE 0.018" WAS INSERTED IN THE MICROCATHETER; HOWEVER FRICTION WAS EXPERIENCED WHEN THE GUIDE PASSED THROUGH FLATTENS AND KINKED SECTIONS. HOWEVER THE GUIDE WIRE CAME OUT OF THE MICROCATHETER'S TIP. THE GUIDE WIRE WAS REMOVED WITHOUT ANY PROBLEM. WITH ATTEMPT TO ADVANCE THE RETURNED ENTERPRISE DELIVERY WIRE THROUGH THE RETURNED MICROCATHETER, RESISTANCE AND FRICTION WAS FELT WHEN THE DELIVERY WIRE PASSED THE KINKED/BENT AREAS OF THE MICROCATHETER AND COULD NOT BE ADVANCED PAST THE PRONOUNCED KINKED AT 98CM FROM THE DISTAL END. A LAB SAMPLE ENTERPRISE VRD WAS INTRODUCED IN TO THE MICROCATHETER; HOWEVER FRICTION WAS EXPERIENCED WHEN IT PASSED THROUGH THE KINKED SECTION AND AFTER THAT THE STENT WAS STUCK ON THE FLATTEN SECTION; IT COULD NOT CAME OUT OF THE MICROCATHETER'S TIP. THE REPORTED KINKED STENT COULD NOT BE EVALUATED SINCE THE STENT WAS NOT RETURNED. THE RESISTANCE AND INABILITY TO INTRODUCE THE ENTERPRISE INTO THE MICROCATHETER AND KINKED MICROCATHETER WERE CONFIRMED. WITH FUNCTIONAL TESTING THE REPORTED ENTERPRISE INSERTION DIFFICULTIES WAS DUE TO THE FLATTENED AND KINKED SECTIONS ON THE MICROCATHETER. THE EXACT CAUSE OF THESE DAMAGES CANNOT BE CONCLUSIVELY DETERMINED. INSPECTIONS ARE IN PLACE TO PREVENT KINKS/FLATTEN DAMAGES ON MICROCATHETER FROM LEAVING THE FACILITY. WITH REVIEW OF THE AVAILABLE INFORMATION REPORTING KINKING OF THE MICROCATHETER AFTER REMOVAL AND ANALYSIS OF THE DEVICES, IT APPEARS THAT PROCEDURAL FACTORS OF VESSEL CHARACTERISTICS AND/OR DEVICE MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION OF ANY RELATED DEVICE MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424848. 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. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00225 & 1058196-2011-00226.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00225 & 1058196-2011-00226. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE, THERE WAS INABILITY TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MICROCATHETER SELECT 150/5 CM 45 SHAPE, AND AFTER REMOVAL, IT WAS NOTED THAT PROXIMAL SHAFT OF THE MICROCATHETER WAS KINK, AS WELL AS THE ENTERPRISE STENT. THE REPORTED EVENT OCCURRED WHEN THE ENTERPRISE WAS BEING ADVANCED THROUGH THE MICROCATHETER AND IT IS UNKNOWN IF THERE WAS ANY RESISTANCE/FRICTION BETWEEN THE ENTERPRISE SYSTEM AND MICROCATHETER OR IF A GUIDEWIRE INSERTED TO EXCHANGE THE MICROCATHETER. AFTER THE EVENT, IT IS UNKNOWN IF THE DELIVERY SYSTEM AND MICROCATHETER WERE REMOVED WAS A UNIT, BUT THE SAME MICROCATHETER WAS NOT UTILIZED TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT RE-SHAPED, AND A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM (KINK, BEND, SEPARATED OR FRACTURE, ETC), DISTAL TIP (UNRAVEL, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), STENT (FRACTURE, SEPARATED, ETC) OR MICROCATHETER (FRACTURE, SEPARATED, ETC). THE TARGET SITE WAS THE (P-COM) POSTERIOR COMMUNICATING 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 01424848

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR SELECT MICROCATHETER