BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2166257 · Received July 18, 2011

    Report

    Report Number
    1058196-2011-00360
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    May 6, 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 STENT ENTERPRISE WAS RECEIVED. THE DELIVERY WIRE WAS NOT RETURNED FOR ANALYSIS. THE STENT WAS RECEIVED DEPLOYED AND ATTACHED IN A SMALL PLASTIC BAG INSIDE THE BIG ONE. THE STENT ENTERPRISE WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND. FUNCTIONAL TEST COULD NOT BE PERFORMED, SINCE NO COMPONENTS WERE RETURNED, EXCEPT THE STENT ENTERPRISE. LAKE REGION LOT NUMBER 01424295 WHICH IS CORDIS LOT NUMBER 01424295. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424295. 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 REPORTED COMPLAINT AS "RESISTANCE/FRICTION - DELIVERY WIRE" WAS NOT CONFIRMED. SINCE THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED (NO COMPONENTS WERE RETURNED, EXCEPT THE STENT). THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE REPORTED COMPLAINT IS RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; 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 MFR REPORT 1058196-2011-00360 AND 1058196-2011-00361.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A NEUROVASCULAR PROCEDURE, THERE WAS RESISTANCE/FRICTION WHEN THE ENTERPRISE STENT WAS ADVANCED THROUGH THE PROWLER 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 2.6 ~2.7 MM, AND THE SIDEWALL ANEURYSM SIZE WAS 6 MM, NECK WAS 4MM, AND THE NECK TO SAC RATIO WAS 6:4. 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. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONLY ONE STENT ENTERPRISE WAS RECEIVED. NEITHER THE DELIVERY WIRE NOR THE MICROCATHETER INVOLVED IN THE COMPLAINT WAS RETURNED FOR ANALYSIS. THE STENT WAS RECEIVED DEPLOYED AND ATTACHED IN A SMALL PLASTIC BAG INSIDE THE BIG ONE. THE STENT ENTERPRISE WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON IT. FUNCTIONAL TEST PER (B)(4) COULD NOT BE PERFORMED, SINCE NO COMPONENTS WERE RETURNED, EXCEPT THE STENT ENTERPRISE. LAKE REGION LOT NUMBER 01424295 IS CORDIS LOT NUMBER 01424295. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424295. 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 REPORTED COMPLAINT AS RESISTANCE/FRICTION "DELIVERY WIRE" WAS NOT CONFIRMED. THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE REPORTED COMPLAINT IS RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE REPORTED COMPLAINT AS "RESISTANCE/FRICTION - DELIVERY WIRE" WAS NOT CONFIRMED AS THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED (NO OTHER COMPONENTS WERE RETURNED, EXCEPT THE STENT). THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. REPORTED FAILURE BY THE CUSTOMER AS "CATHETER - FRICTION IN INNER LUMEN" WAS NOT CONFIRMED DURING THE FUNCTIONAL TEST. 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 LIMITED INFORMATION DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00360 AND 1058196-2011-00361.

    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 2.6-2.7 MM, AND THE SIDEWALL ANEURYSM SIZE WAS 6 MM, NECK WAS 4MM, AND THE NECK TO SAC RATIO WAS 6:4. 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 01424295

    Patients

    Seq Age Sex Outcome Treatment
    1 SELECT PLUS 150/5 CM