BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2093252 · Received May 18, 2011

    Report

    Report Number
    1058196-2011-00242
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 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

    ONE NON STERILE ENTERPRISE STENT WAS RECEIVED WITH A PROWLER SELECT PLUS FOR ANALYSIS, BOTH INSIDE OF A PLASTIC BAG. THE STENT WAS RECEIVED PARTIALLY DEPLOYED INSIDE OF THE MICROCATHETER HUB. THE MICROCATHETER PRESENTED TWO KINKED CONDITIONS AT 40.9CM AND 41.8CM FROM DISTAL END. NO OTHER VISUAL ANOMALY WAS NOTED ON THE RECEIVED UNITS. THE STENT WAS REMOVED FROM MICROCATHETER HUB AND WAS INSPECTED UNDER A MICROSCOPE; NO DAMAGE WAS NOTED ON IT. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED SINCE ONLY A DEPLOYED STENT WAS RECEIVED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427410. 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. THIS PACKAGING LOT CONTAINED 100 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(6) 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE "DELIVERY WIRE-IMPEDED-IN MICROCATHETER" COULD NOT BE EVALUATED SINCE THE DELIVERY WIRE WAS NOT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED OF THE PRODUCT, THEREFORE NO 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 MFG REPORT 1058196-2011-00242 AND 1058196-2011-00243. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ONE NON STERILE ENTERPRISE STENT WAS RECEIVED WITH A PROWLER SELECT PLUS FOR ANALYSIS, BOTH INSIDE OF A PLASTIC BAG. THE STENT WAS RECEIVED PARTIALLY DEPLOYED INSIDE OF THE MICROCATHETER HUB. THE MICROCATHETER PRESENTED TWO KINKED CONDITIONS AT 40.9CM AND 41.8CM FROM DISTAL END. NO OTHER VISUAL ANOMALY WAS NOTED ON THE RECEIVED UNITS. THE STENT WAS REMOVED FROM MICROCATHETER HUB AND WAS INSPECTED UNDER A MICROSCOPE; NO DAMAGE WAS NOTED ON IT. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED SINCE ONLY A DEPLOYED STENT WAS RECEIVED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427410. 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 100 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON OCTOBER 22, 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 THE CUSTOMER AS "STENT-DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER HUB" WAS CONFIRMED OWING TO RECEIVED CONDITION OF THE DEVICE; HOWEVER THIS FAILURE DOES NOT APPEARS TO MANUFACTURING RELATED OF THE PRODUCT, PROCEDURAL FACTORS MAY HAVE IMPACTED ON THIS EVENT EXPERIENCED DURING PROCEDURE. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED OF THE PRODUCT, THEREFORE NO 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 1058196-2011-00242 AND 1058196-2011-00243. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING A COIL EMBOLIZATION PROCEDURE THE SELECT PLUS MICROCATHETER WAS OBSTRUCTED AND KINKED IN THE PATIENT AND THE ENTERPRISE VRD SYSTEM DELIVERY WIRE WAS IMPEDED IN MICROCATHETER AND THE STENT HAD PREMATURE DEPLOYMENT IN THE MICROCATHETER. THERE ARE NO PATIENT OR TARGET LESION DETAILS AVAILABLE TO DATE. THE INFORMATION RECEIVED INDICATED THAT DURING A COIL EMBOLIZATION PROCEDURE, AN ENTERPRISE SYSTEM ((B)(4)) WAS ADVANCED VIA THE SELECT PLUS 150/5 CM MICROCATHETER, BUT IT STOP ADVANCING THROUGH THE MICROCATHETER. BOTH PRODUCTS THE ENTERPRISE SYSTEM AND MICROCATHETER, WERE REMOVED AS A UNIT FROM THE PATIENT. AFTER REMOVAL, THE MICROCATHETER WAS KINKED IN THE MIDDLE AND THE STENT REMAINED IN THE HUB. ALL THE PRODUCTS WERE PREP PER LABELING INSTRUCTIONS. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON STERILE ENTERPRISE STENT WAS RECEIVED WITH A PROWLER SELECT PLUS FOR ANALYSIS, BOTH INSIDE OF A PLASTIC BAG. THE STENT WAS RECEIVED PARTIALLY DEPLOYED INSIDE OF THE MICROCATHETER HUB. THE MICROCATHETER PRESENTED TWO KINKED CONDITIONS AT 40.9CM AND 41.8CM FROM DISTAL END. NO OTHER VISUAL ANOMALY WAS NOTED ON THE RECEIVED UNITS. THE STENT WAS REMOVED FROM MICROCATHETER HUB AND WAS INSPECTED UNDER A MICROSCOPE; NO DAMAGE WAS NOTED ON IT. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED SINCE ONLY A DEPLOYED STENT WAS RECEIVED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427410. 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 REPORTED FAILURE BY THE CUSTOMER AS "STENT-DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER HUB" WAS CONFIRMED OWING TO RECEIVED CONDITION OF THE DEVICE; HOWEVER THIS FAILURE DOES NOT APPEARS TO MANUFACTURING RELATED OF THE PRODUCT, PROCEDURAL FACTORS MAY HAVE IMPACTED ON THIS EVENT EXPERIENCED DURING PROCEDURE. THE FAILURE "DELIVERY WIRE-IMPEDED-IN MICROCATHETER" COULD NOT BE EVALUATED SINCE THE DELIVERY WIRE WAS NOT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED OF THE PRODUCT, THEREFORE NO 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 MFG REPORT 1058196-2011-00242 AND 1058196-2011-00243.

    Description of Event or Problem · 1

    THE INITIAL INFORMATION INDICATED THAT THE ENTERPRISE PRE-DEPLOYED IN THE HUB AND THE MICROCATHETER WAS KINKED. HOWEVER, ADDITIONAL INFORMATION INDICATED THAT DURING A COIL EMBOLIZATION PROCEDURE, AN ENTERPRISE SYSTEM (ENF452812) WAS ADVANCED VIA THE SELECT PLUS 150/5 CM MICROCATHETER, BUT IT STOP ADVANCING THROUGH THE MICROCATHETER. BOTH PRODUCTS THE ENTERPRISE SYSTEM AND MICROCATHETER, WERE REMOVED AS A UNIT FROM THE PATIENT. AFTER REMOVAL, THE MICROCATHETER WAS KINKED IN THE MIDDLE AND THE STENT REMAINED IN THE HUB. ALL THE PRODUCTS WERE PREP PER LABELING INSTRUCTIONS. NO FURTHER INFORMATION WAS AVAILABLE.

    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 01427410

    Patients

    Seq Age Sex Outcome Treatment
    1 SLECT PLUS MICROCATHETER