BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4103115 · Received September 19, 2014

    Report

    Report Number
    1058196-2014-00230
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE ISSUE. THERE WAS NO RESISTANCE FELT THROUGH THE HEADWAY 17 MICROCATHETER OR PROWLER SELECT PLUS MICROCATHETER. NO KINKS OR BENDS ON ANY OF THE PRODUCTS WERE REPORTED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO DIFFICULTY TRACKING THE CATHETER TO THE TARGET SITE OR EXCESSIVE MANIPULATION/TORQUING REQUIRED PRIOR TO INTRODUCTION OF THE DEVICE. CATALOG NUMBER 606S255X FOR THE PROWLER SELECT PLUS WAS OBTAINED. PRODUCT ANALYSIS: A NON-STERILE UNIT OF ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. DELIVERY WIRE WAS RECEIVED INSIDE OF ITS COIL DISPENSER; THE STENT INVOLVED WAS RECEIVED DEPLOYED. THE MICROCATHETER INVOLVED WAS NOT RECEIVED FOR ANALYSIS. NO ANOMALIES WERE FOUND DURING VISUAL ANALYSIS. THE TEST WAS PERFORMED. THE FUNCTIONAL ANALYSIS WAS PERFORMED WITHOUT THE STENT BECAUSE THE STENT WAS RECEIVED DEPLOYED. SINCE MICROCATHETER AND INTRODUCER TUBE WERE NOT RECEIVED FOR ANALYSIS, LAB SAMPLES WERE USED TO PERFORM FUNCTIONAL ANALYSIS. THE GUIDEWIRE COMPLETELY PASSED THROUGH THE MICROCATHETER SUCCESSFULLY WITH NO ANOMALIES DETECTED DURING THE TEST. STENT WAS ANALYZED UNDER VISION SYSTEM AND NO ANOMALIES WERE FOUND. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION AND PACKAGING OF LOT 10367366. 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 FAILURE THAT THE STENT COULD NOT BE ADVANCED INTO THE MICROCATHETER COULD NOT BE CORRECTLY EVALUATED BECAUSE THE STENT WAS RECEIVED DEPLOYED; HOWEVER THE FUNCTIONAL TEST WAS PERFORMED SUCCESSFULLY WITHOUT THE STENT. THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, PROCEDURAL / HANDLING FACTORS MIGHT HAVE CONTRIBUTED TO THOSE ISSUES. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING STENT-ASSISTED EMBOLIZATION OF A POSTERIOR COMMUNICATING ARTERY (5X7 MM) FRICTION WAS FELT IN THE MICROCATHETER AND THE ENTERPRISE STENT (ENC452812/10367366) COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE SURGEON PUT A 6F ENVOY (DETAILS UNKNOWN) TO ESTABLISH ACCESS AND PROWLER SELECT PLUS (DETAILS UNKNOWN) IN PLACE. THE OTHER MICROCATHETER USED WAS HEADWAY 17 FROM MICROVENTION (DETAILS UNKNOWN). TWO COILS HAD BEEN POSITIONED SMOOTHLY. THE SURGEON FELT FRICTION AND THE STENT COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE SURGEON TRIED TO WITHDRAW THE STENT BUT STILL FAILED. FINALLY THE SURGEON REMOVED THEM AS A UNIT AND CHANGED ANOTHER STENT TO COMPLETE. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582017 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10367366

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR