BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2162678 · Received July 14, 2011

    Report

    Report Number
    1058196-2011-00356
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON-STERILE ENTERPRISE WAS RECEIVED IN A PLASTIC BAG. THE STENT WAS RECEIVED INSIDE THE INTRODUCER TUBE. THE GUIDE WIRE SHOWED NO ANOMALIES. THE INTRODUCER TUBE WAS SEATED INTO A MICROCATHETER HUB LAB SAMPLE, IT WAS INSPECTED UNDER MICROSCOPE AND NO GAPS WERE OBSERVED BETWEEN THE INTRODUCER AND MICROCATHETER HUB LAB SAMPLE. FUNCTIONAL ANALYSIS WAS PERFORMED WITHOUT ANY DIFFICULTY. LR PACKAGING L/N# 01425619. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425619. 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. THE COMPLAINT REPORTED BY THE CUSTOMER AS: "DELIVERY WIRE- RESISTANCE/FRICTION" WAS NOT CONFIRMED SINCE FUNCTIONAL ANALYSIS WAS PERFORMED WITHOUT ANY DIFFICULTY. THE EXACT CAUSE OF THIS EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THIS FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS 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 MFR REPORT 1058196-2011-00356 AND 1058196-2011-00357. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A NEUROVASCULAR PROCEDURE THE ENTERPRISE STENT HAD RESISTANCE/FRICTION DURING ADVANCEMENT THROUGH A PROWLER SELECT PLUS 150/5CM (MC) MICROCATHETER. THE EVENT OCCURRED DURING ADVANCING THROUGH THE MICROCATHETER, BUT THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE ENTERPRISE SYSTEM AND MICRO CATHETER WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT. A GUIDEWIRE WAS NOT UTILIZED TO EXCHANGE THE MICROCATHETER. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE MC WAS NOT RE-SHAPED PRIOR TO USE. THE TARGET SITE WAS INTRACEREBRAL WITH A VESSEL DIAMETER OF 3.5 MM, AND THE BIFURCATING ANEURYSM SIZE WAS 7MM AND THE NECK WAS 3MM. THE STENT WAS NOT RE-INSERTED IN THE INTRODUCER/DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE STENT (UPLIFTED STRUTS, KINK BEND, FRACTURE, SEPARATED, ETC), DELIVERY SYSTEM (KINK, BEND, FRACTURE, SEPARATED, ETC), DISTAL TIP (UNRAVELED, KINK, BEND, FRACTURE SEPARATED, ETC), INTRODUCER OR MICROCATHETER. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE BODY SHAFT OF MICROCATHETER WAS INSPECTED AND IT WAS FOUND TO BE KINKED AS WELL AS COMPRESSED IN SECTIONS. NO OTHER VISUAL ANOMALY WAS NOTED ON THE RECEIVED UNIT. THE MICRO CATHETER WAS INSPECTED UNDER A MICROSCOPE AND THE DAMAGES FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED. (COMPRESSED SECTION AND KINKS). THE ID FROM THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE NIPRO, AFTER THAT AN ENTERPRISE (CORDIS - LAB SAMPLE), WAS INTRODUCED IN TO THE MICROCATHETER AND IT ADVANCE SMOOTHLY; UNTIL IT GETS STUCK IN ONE OF THE COMPRESSED SECTIONS FOUND ON THE DEVICE AND COULDN'T ADVANCE MORE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED FAILURE AS "CBS - RESISTANCE/FRICTION INNER LUMEN" WAS CONFIRMED DURING THE ANALYSIS. THE RESISTANCE FRICTION EXPERIENCED BY THE COSTUMER WAS DUE TO THE KINKS AND COMPRESSED SECTIONS FOUND ON THE DEVICE. THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REPORTED FAILURE AS "MICROCATHETER - RESISTANCE/FRICTION INNER LUMEN" WAS CONFIRMED DURING THE ANALYSIS. THE RESISTANCE FRICTION EXPERIENCED BY THE COSTUMER WAS DUE TO THE KINKS AND COMPRESSED SECTIONS FOUND ON THE DEVICE. THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT REPORTED BY THE CUSTOMER AS: "ENTERPRISE DELIVERY WIRE- RESISTANCE/FRICTION" WAS NOT CONFIRMED SINCE FUNCTIONAL ANALYSIS WAS PERFORMED WITHOUT ANY DIFFICULTY. THE EXACT CAUSE OF THIS EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL AND HANDLING ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED AND CONFIRMED EVENTS.

    Description of Event or Problem · 1

    DURING A NEUROVASCULAR PROCEDURE, THERE WAS RESISTANCE WHEN THE ENTERPRISE STENT WAS ADVANCED VIA THE SELECT PLUS 150/5CM (MC) MICROCATHETER, THEREFORE THE ENTERPRISE AND MICROCATHETER WERE REMOVED FROM THE PATIENT AS A UNIT. THE EVENT OCCURRED DURING ADVANCING THROUGH THE MICROCATHETER, BUT THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. A GUIDEWIRE WAS NOT UTILIZED TO EXCHANGE THE MICROCATHETER AND MAINTAINED TARGET SITE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE MC WAS NOT RE-SHAPED PRIOR TO USE. THE TARGET SITE WAS INTRACEREBRAL WITH A VESSEL DIAMETER OF 3.5 MM, AND THE BIFURCATING ANEURYSM SIZE WAS 7MM AND THE NECK WAS 3MM. THE STENT WAS NOT COMPLETED RE-INSERTED IN THE INTRODUCER/DELIVERY SYSTEM, BUT NO DAMAGES WERE NOTICED ON THE STENT (UPLIFTED STRUTS, KINK BEND, FRACTURE, SEPARATED, ETC), DELIVERY SYSTEM (KINK, BEND, FRACTURE, SEPARATED, ETC), DISTAL TIP (UNRAVELED, KINK, BEND, FRACTURE SEPARATED, ETC), INTRODUCER OR MICROCATHETER.

    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 01425619

    Patients

    Seq Age Sex Outcome Treatment
    1 SELECT PLUS 150/5CM (MC) MICROCATHETER