BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1951195 · Received January 6, 2011

    Report

    Report Number
    1058196-2011-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VRD AND DELIVERY SYSTEM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS RECEIVED DEPLOYED INSIDE OF A SMALL PLASTIC BAG. THE INTRODUCER TUBE PRESENTED DRY BLOOD RESIDUALS IN THE DISTAL SECTION. THE ENTERPRISE COIL TIP WAS OBSERVED UNDER A MICROSCOPE AND TWO KINKED CONDITIONS WERE FOUND AT 4CM AND 9CM FROM THE DISTAL END. THE INTRODUCER TUBE WAS SEATED INTO A MICROCATHETER HUB LAB SAMPLE, AND NO GAPS BETWEEN THE INTRODUCER AND MICROCATHETER WERE NOTED. THE ENTERPRISE STENT WAS OBSERVED UNDER A MICROSCOPE AND PRESENTED A FRACTURE, THE PRODUCT WAS SENT TO SEM FOR FURTHER ANALYSIS. THE SEM RESULTS SHOWED THAT THE STENT PRESENTED EVIDENCE OF BROKEN STRUTS; FRACTURED STRUT, SMEARING CAN BE OBSERVED IN THE EDGES OF THE FAILURE SITE. NO CUTTING OR CHEMICAL ATTACK CHARACTERISTICS WERE NOTED IN THE FRACTURE SURFACES, INSTEAD DUCTILE DIMPLES CAN BE OBSERVED IN THE FRACTURE SURFACE WHICH SUGGESTS PULLING UNTIL FAILURE. THE EXACT CAUSES OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE THE STENT WAS RECEIVED DEPLOYED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01418938. 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 73 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON JANUARY 19, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE STENT DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER HUB REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS NOT RECEIVED IN THE MICROCATHETER HUB, HOWEVER THE ENTERPRISE STENT WAS RECEIVED DEPLOYED INSIDE A PLASTIC BAG. PROCEDURAL/HANDLING FACTORS APPEAR TO HAVE IMPACTED ON THE FAILURE EXPERIENCED BY THE CUSTOMER. PROCEDURAL/HANDLING FACTORS APPEAR TO HAVE IMPACTED ON THE FAILURE EXPERIENCED BY THE CUSTOMER. THE STENT FRACTURE OBSERVED DURING MICROSCOPIC ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED ACCORDING WITH THE SEM ANALYSIS RESULTS. NEITHER THE PRODUCT NOR SEM ANALYSIS SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE WAS PRE-DEPLOYED IN THE MICROCATHETER HUB. THE ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FRACTURED. IT WAS REPORTED THAT PRIOR AND AFTER REMOVAL FROM THE PACKAGE, THE PRODUCTS WERE NOT DAMAGED. ALL THE PRODUCTS WERE PREP PER LABELING INSTRUCTIONS. NEITHER THE MICROCATHETER NOR THE ENTERPRISE TIPS WERE RE-SHAPED. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. A PROWLER SELECT PLUS STR MICROCATHETER WAS UTILIZED WITH THE ENTERPRISE SYSTEM. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. IT COULD NOT BE CONFIRMED WHETHER THE ENTERPRISE INTRODUCER WAS FULLY SEATED AND SECURED IN THE MICROCATHETER HUB DURING INTRODUCTION. AFTER REMOVAL FROM THE PATIENT, NEITHER DEVICE (ENTERPRISE DELIVERY SYSTEM (DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC), STENT (STRUT UPLIFT OR DEFORMED, ETC), OR MICROCATHETER) WAS DAMAGED. THE TARGET SITE WAS A SACCULAR ANTERIOR COMMUNICATING (ACOM) ARTERY. ONE NON STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS RECEIVED DEPLOYED INSIDE OF A SMALL PLASTIC BAG. THE INTRODUCER TUBE PRESENTED DRY BLOOD RESIDUALS IN THE DISTAL SECTION. THE ENTERPRISE COIL TIP WAS OBSERVED UNDER A MICROSCOPE AND TWO KINKED CONDITIONS WERE FOUND AT 4CM AND 9CM FROM THE DISTAL END. FOR FUNCTIONAL TESTING THE INTRODUCER TUBE WAS SEATED INTO A LAB SAMPLE MICROCATHETER HUB AND NO GAPS BETWEEN THE INTRODUCER AND MICROCATHETER WERE NOTED. THE ENTERPRISE STENT WAS OBSERVED UNDER A MICROSCOPE AND PRESENTED A FRACTURE, THE PRODUCT WAS SENT TO SEM FOR FURTHER ANALYSIS. THE SEM RESULTS SHOWED THAT THE STENT PRESENTED EVIDENCE OF BROKEN STRUTS; FRACTURED STRUT, SMEARING CAN BE OBSERVED IN THE EDGES OF THE FAILURE SITE. NO CUTTING OR CHEMICAL ATTACK CHARACTERISTICS WERE NOTED IN THE FRACTURE SURFACES, INSTEAD DUCTILE DIMPLES CAN BE OBSERVED IN THE FRACTURE SURFACE WHICH SUGGESTS PULLING UNTIL FAILURE. THE EXACT CAUSES OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED WITH ANALYSIS. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE STENT WAS RECEIVED DEPLOYED; IS NECESSARY THAT THE STENT IS STILL INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01418938. 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) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. ALTHOUGH THE PREMATURE DEPLOYMENT IN THE HUB COULD NOT BE CONFIRMED; IT WAS CONFIRMED THAT THE STENT WAS DEPLOYED. THE INTRODUCTION PROCEDURE OF THE ENTERPRISE VRD IS TECHNIQUE DRIVEN; REQUIRING PROPER ORIENTATION AND POSITIONING OF EACH COMPONENT OF THE SYSTEM. IF PRIOR TO INTRODUCTION OF THE STENT FULLY WITHIN THE MICROCATHETER, THE INTRODUCER IS NOT FULLY SEATED IN THE MICROCATHETER HUB OR THERE IS MOVEMENT OF THE INTRODUCER RESULTING IN A GAP, THE PROXIMAL END OF THE STENT WILL EXPAND AS IT ENTERS THE GAP. IF THE INTRODUCER IS NOT SECURED, IT WILL MOVE AND THE GAP WILL EXPAND RESULTING IN PREMATURE DEPLOYMENT OF THE STENT IN THE MICROCATHETER HUB. IT IS LIKELY THAT CONTINUED ATTEMPTED ADVANCEMENT OF THE DEVICE IN THE PRESENCE OF THIS SCENARIO CONTRIBUTED TO THE DAMAGES FOUND ON THE RETURNED STENT. THE CAUSE OF THE STENT FRACTURE OBSERVED DURING MICROSCOPIC ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, BASED ON THE ANALYSIS IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. PROCEDURAL/HANDLING FACTORS APPEAR TO HAVE IMPACTED THE REPORTED EVENT AND CONDITION OF THE RETURNED DEVICE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE INITIAL REPORT INDICATED THAT THE ENTERPRISE WAS PRE-DEPLOYED IN THE MICROCATHETER HUB. HOWEVER THE SYSTEM WAS RECEIVED FOR ANALYSIS, AND THE STENT DISTAL SECTION HAD A FRACTURE SECTION. PRIOR AND AFTER REMOVAL FROM THE PACKAGE, THE PRODUCTS WERE NOT DAMAGED. ALL THE PRODUCTS WERE PREP PER LABELING INSTRUCTIONS. NEITHER THE MICROCATHETER NOR THE ENTERPRISE TIPS WERE RE-SHAPED. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. A PROWLER SELECT PLUS STR MICROCATHETER WAS UTILIZED WITH THE ENTERPRISE SYSTEM. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. AFTER REMOVAL FROM THE PATIENT, NEITHER DEVICE (ENTERPRISE DELIVERY SYSTEM (DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC), STENT (STRUT UPLIFT OR DEFORMED, ETC), OR MICROCATHETER) WAS DAMAGED. THE TARGET SITE WAS THE ACOM ARTERY WITH A SACCULAR AND NO ANOMALY ANEURYSM.

    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 13471834

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER