BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3033665 · Received April 3, 2013

    Report

    Report Number
    1058196-2013-00084
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    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

    (B)(6) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10138492. 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)(6)'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER, IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: - PROWLER SELECT PLUS MICROCATHETER (DETAILS UNKNOWN). - UNKNOWN STENT. - SELECT PLUS 150/5 CM MICROCATHETER (606S255X/15727745).

    Additional Manufacturer Narrative · 1

    DURING TREATMENT OF A LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM THE ENTERPRISE STENT (ENC452212/10138492) COULD NOT BE ADVANCED IN BOTH THE FIRST MICROCATHETER (PROWLER SELECT PLUS, DETAILS UNKNOWN) AND THE NEW SECOND MICROCATHETER SELECT PLUS 150/5 CM (606S255X/15727745). THE FIRST MICROCATHETER AND STENT WERE NOT WITHDRAWN TOGETHER AS A UNIT. THE STENT WAS STUCK IN THE SECOND MICROCATHETER DURING WITHDRAWAL SO THE STENT AND SECOND MICROCATHETER WERE WITHDRAWN TOGETHER AS A UNIT. HOWEVER, THE STENT DROPPED FROM THE SECOND MICROCATHETER WHEN IT WAS WITHDRAWN OUT OF THE PATIENT'S BODY AND WAS UNABLE TO BE FOUND IN THE OPERATING ROOM. THE FIRST MICROCATHETER AND A NEW STENT (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE FIRST AND SECOND MICROCATHETER PRIOR TO AND AFTER USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE FIRST AND SECOND MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE STENT PRIOR TO USE. IT WAS INDICATED THAT THERE WAS NO RELATED POTENTIAL ADVERSE EVENT. (B)(4): A NON-STERILE PROWLER SELECT PLUS 150/5 CM MICROCATHETER (MC) WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. AN ENTERPRISE DELIVERY WIRE WAS FOUND INSIDE OF THE MC. THE MC WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. NO DAMAGES WERE NOTED O THE HUB. THE ID OF THE MC WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE PROWLER SELECT PLUS MC WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO). FUNCTIONAL TEST WAS PERFORMED WITH THE DELIVERY WIRE AS RECEIVED WITHOUT THE STENT. AS REPORTED THE STENT DEPLOYED OUT OF THE END OF THE MC AFTER REMOVAL FROM THE PATIENT. THE DELIVERY WIRE WAS INSERTED AND ADVANCE THROUGH THE MC IT WAS RECEIVED IN WITHOUT ANY DIFFICULTIES. AFTER THAT; AN ENTERPRISE LAB SAMPLE WAS INTRODUCED INTO THE MC AND IT ADVANCED SMOOTHLY THROUGH TO THE MC DISTAL TIP WITHOUT ANY DIFFICULTY. 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. THERE WAS NO RESISTANCE/FRICTION OR INABILITY TO INSERT CONCOMITANT DEVICES THROUGH THE RETURNED PROWLER SELECT PLUS WITH FUNCTIONAL TESTING. BASED ON THE ANALYSIS THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE REPORTED EVENT. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. (B)(4); ONE NON-STERILE ENTERPRISE VRD DELIVERY WIRE WAS RECEIVED COILED IN A PLASTIC BAG; THE UNIT WAS RECEIVED INSIDE A PROWLER SELECT PLUS MICROCATHETER (MC). THE SAMPLE WAS INSPECTED AND NO ANOMALIES/DAMAGES WERE FOUND. NEITHER THE STENT NOR THE INTRODUCER WAS RECEIVED WITHIN THIS BAG. AS REPORTED THE STENT DEPLOYED OUT OF THE END OF THE MC AFTER REMOVAL FROM THE PATIENT. THE MC WAS ALSO VISUALLY INSPECTED AND NO ANOMALIES/DAMAGES WERE NOTED. THE DELIVERY WIRE COIL TIP WAS OBSERVED UNDER A MICROSCOPE AND NO ANOMALIES/DAMAGES WERE NOTED. FUNCTIONAL TEST WAS PERFORMED WITH THE DELIVERY WIRE AS RECEIVED WITHOUT THE STENT. USING A LAB SAMPLE INTRODUCER THE RETURNED ENTERPRISE DELIVERY WIRE WAS INSERTED AND ADVANCE THROUGH THE MC IT WAS RECEIVED IN. NO ANOMALIES WERE NOTED. THE DELIVERY WIRE PASSED COMPLETELY THROUGH THE RETURNED MC. ADDITIONALLY A LAB SAMPLE ENTERPRISE WITH THE STENT WAS PASSED THROUGH THE CONCOMITANT MC WITHOUT ANY DIFFICULTY. RESISTANCE WITH INSERTION OF A LAB SAMPLE ENTERPRISE THROUGH THE SECOND MC THAT WAS USED WITH THE ENTERPRISE WAS CONFIRMED AND WAS DUE TO COMPRESSIONS ON THE MC. THE TIMING OF THESE COMPRESSIONS AND IMPACT ON THE PROCEDURAL EVENT CANNOT BE DETERMINED; HOWEVER, IT WAS REPORTED THAT THE SECOND MC WAS USED SUCCESSFULLY WITH A SECOND ENTERPRISE. (B)(4) REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10138492. 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. THE REPORTED INABILITY TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MCS COULD NOT BE FULLY EVALUATED SINCE AS REPORTED THE STENT WAS DEPLOYED AFTER REMOVAL FROM THE PATIENT AND WAS NOT RETURNED FOR INSPECTION. THERE WERE NO DISCREPANCIES OR ABNORMALITIES FOUND WITH ANALYSIS AND FUNCTIONAL TESTING OF THE RETURNED ENTERPRISE DELIVERY WIRE OR WITH THE MC IT WAS RECEIVED IN. IT IS POSSIBLE THAT PROCEDURAL FACTORS/VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT; HOWEVER, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES IMPACTING THE EVENT. THE DEVICE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4); A NON-STERILE PROWLER SELECT PLUS MICROCATHETER (MC) WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE MC WAS INSPECTED AND COMPRESSED SECTIONS WERE NOTED ON IT. NO DAMAGES WERE NOTED O THE HUB. THE ID OF THE MC WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE MC WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND AFTER THAT A 0.018" A GUIDE WIRE CORDIS LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP. SEVERE RESISTANCE/FRICTION WAS FELT WHEN THE GUIDE WIRE WAS PASS THROUGH OF THE COMPRESSED SECTIONS. AFTER THAT THE MC WAS FLUSHED AGAIN AND AN ENTERPRISE LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT COULD NOT PASS THROUGH THE MC DUE TO THE COMPRESSED SECTIONS FOUND ON THE MICROCATHETER. 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. WITH FUNCTIONAL TESTING THERE WAS RESISTANCE/FRICTION AT THE DISTAL END OF THE MC WITH INSERTION OF CONCOMITANT DEVICES WHICH WAS DUE TO THE COMPRESSED SECTION FOUND ON THE MC. BASED ON THE ANALYSIS THE CAUSE AND TIMING OF THE COMPRESSED DAMAGE CANNOT BE DETERMINED. IT IS POSSIBLE THAT IF THERE WAS SOME KINKING OR COMPRESSION OF THE DEVICE DURING PROCEDURAL USE, THIS MAY HAVE IMPACTED THE REPORTED EVENT. HOWEVER, BASED ON THE REPORT THAT AFTER THE INABILITY TO ADVANCE THE ENTERPRISE VRD SYSTEM A SECOND ENTERPRISE SYSTEM WAS SUCCESSFULLY ADVANCED AND DEPLOYED USING THIS SAME MC, THE DAMAGES FOUND ON THE DEVICE THAT PREVENTED ADVANCEMENT OF CONCOMITANT DEVICES DURING FUNCTIONAL TESTING CAN BE ATTRIBUTED TO POST PROCEDURAL HANDLING. WITH REVIEW OF THE REPORTED INFORMATION AND THE ANALYSIS, THERE IS NO INDICATION THAT THE DAMAGES ARE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURES FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE ENTERPRISE STENT (ENC452212/10138492) COULD NOT BE ADVANCED IN BOTH THE FIRST MICROCATHETER (PROWLER SELECT PLUS, DETAILS UNKNOWN) AND THE NEW SECOND MICROCATHETER SELECT PLUS 150/5 CM ((B)(4)/15727745). THE FIRST MICROCATHETER AND STENT WERE NOT WITHDRAWN TOGETHER AS A UNIT. THE STENT WAS STUCK IN THE SECOND MICROCATHETER DURING WITHDRAWAL SO THE STENT AND SECOND MICROCATHETER WERE WITHDRAWN TOGETHER AS A UNIT. HOWEVER, THE STENT DROPPED FROM THE SECOND MICROCATHETER WHEN IT WAS WITHDRAWN OUT OF THE PATIENT'S BODY AND WAS UNABLE TO BE FOUND IN THE OPERATING ROOM. THE FIRST MICROCATHETER AND A NEW STENT (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE FIRST AND SECOND MICROCATHETER PRIOR TO AND AFTER USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE FIRST AND SECOND MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE STENT PRIOR TO USE. THIS IS NOT A POTENTIAL ADVERSE EVENT. THE PATIENT HAD PCOM ON THE LEFT SIDE AND HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137071 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10138492

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR