BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1951161 · Received January 6, 2011

    Report

    Report Number
    1058196-2011-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    August 13, 2010
    Report Date
    August 16, 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 NON-STERILE UNIT WAS RECEIVED IN A PLASTIC BAG. THE CORE WIRE SHOWED NO ANOMALIES. THE DISTAL TIP SHOWED SOME BENTS, THE COIL WIRE WAS UNRAVELED AT THE DISTAL SECTION; THE BENTS AND UNRAVELED CONDITION FOUND IN THE COIL COULD BE RELATED TO THE SHIPPING AND/OR STORAGE OF THE SAMPLE. THE STENT WAS INSPECTED UNDER MICROSCOPE AND IT WAS OBSERVED THAT THE STENT WAS IN GOOD CONDITIONS. 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 COULD NOT BE PERFORMED ACCORDING TO DP (B)(4) SINCE STENT WAS NOT INSIDE THE INTRODUCER. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01421316. THIS PACKAGING LOT CONTAINED 25 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON APRIL 1, 2010. 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: "STENT- DEPLOYMENT DIFFICULTY-PREMATURE/IN MICROCATHETER HUB" WAS NOT CONFIRMED SINCE THE STENT WAS NOT RECEIVED IN THE MICROCATHETER HUB; HOWEVER, THE STENT WAS RECEIVED DEPLOYED. THE ROOT CAUSE OF THIS FAILURE CANNOT 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE, THE ENTERPRISE STENT PRE-DEPLOY IN THE MICROCATHETER HUB. ANALYSIS OF THE RETURNED DEVICE FOUND THE DELIVERY SYSTEM DISTAL TIP WAS UNRAVELED/STRETCHED. DURING INSERTION, THE TOUHY OR Y CONNECTOR WAS CLOSED TO SECURE THE ENTERPRISE INTRODUCER AND PREVENT MOVEMENT, AND THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. AFTER THE EVENT, THE STENT WAS REMOVED FROM THE HUB, AND THE MICROCATHETER WAS KEPT AT THE TARGET SITE. THE TARGET SITE WAS THE PICA THAT WAS TORTUOUS. NO FURTHER INFORMATION WAS AVAILABLE. ONE NON-STERILE UNIT WAS RECEIVED IN A PLASTIC BAG. THE CORE WIRE SHOWED NO ANOMALIES. THE DISTAL TIP SHOWED SOME BENTS, THE COIL WIRE WAS UNRAVELED AT THE DISTAL SECTION; THE BENTS AND UNRAVELED CONDITION FOUND IN THE COIL COULD BE RELATED TO THE SHIPPING AND/OR STORAGE OF THE SAMPLE AFTER PROCEDURAL USE. THE STENT WAS INSPECTED UNDER MICROSCOPE AND IT WAS OBSERVED THAT THE STENT WAS IN GOOD CONDITION. 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 FOR INSERTION INTO A MICROCATHETER COULD NOT BE PERFORMED SINCE STENT WAS NOT INSIDE THE INTRODUCER. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01421316. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PREMATURE DEPLOYMENT IN THE HUB COULD NOT BE CONFIRMED; HOWEVER, IT WAS CONFIRMED THAT THE STENT WAS DEPLOYED. ALTHOUGH IT WAS REPORTED THAT THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE MICROCATHETER HUB, 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 POSSIBLE THAT ADVANCEMENT/MANIPULATION OF THE DEVICE IN THE PRESENCE OF THIS SCENARIO CONTRIBUTED TO THE DAMAGES FOUND ON THE RETURNED DELIVERY WIRE. BASED ON THE ANALYSIS OF THE RETURNED DEVICE, THE ROOT CAUSE OF THIS FAILURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS; THE DEVICE DID NOT PRESENT ANY INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AND CONDITION OF THE RETURNED DEVICE. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE INITIAL REPORT INDICATED THAT DURING AN ASSISTED COIL EMBOLIZATION PROCEDURE, THE ENTERPRISE STENT PRE-DEPLOY IN THE MICROCATHETER HUB. HOWEVER, THE ANALYSIS SHOWED THAT THE DELIVERY SYSTEM DISTAL TIP WAS UNRAVELED/STRETCHED. DURING INSERTION, THE TOUHY OR Y CONNECTOR WAS CLOSED TO SECURE THE ENTERPRISE INTRODUCER AND PREVENT MOVEMENT, AND THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. AFTER THE EVENT, THE STENT WAS REMOVED FROM THE HUB, AND THE MICROCATHETER WAS KEPT AT THE TARGET SITE. THE TARGET SITE WAS THE PICA THAT WAS TORTUOUS. 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 01421316

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER