BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2220651 · Received August 23, 2011

    Report

    Report Number
    1058196-2011-00420
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION CODE WAS CHOSEN FOR THE PATIENT IDENTIFIER, SINCE THERE WAS NO CODE AVAILABLE FOR REPORTED EVENT OF STENT INACCURATE PLACEMENT. PLEASE NOTE: THE CATALOG (B)() REPRESENTS AN UNKNOWN ENTERPRISE VRD. THE CATALOG AND LOT NUMBER FOR THE ACTUAL PRODUCT USED IN THE PATIENT IS UNKNOWN. AN INVESTIGATION IS IN PROCESS TO RETRIEVE THIS INFORMATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THE ENTERPRISE STENT HAD DEPLOYMENT DIFFICULTY WITH INACCURATE PLACEMENT. TO DATE THERE ARE NO PATIENT, VESSEL OR LESION DEMOGRAPHICS AVAILABLE. DURING OFF-LABEL USED OF AN ENTERPRISE STENT TO TREAT A SYMPTOMATIC (MCA) MIDDLE CEREBRAL ARTERY STENOSIS, AN ENTERPRISE STENT MIGRATED DISTAL TO THE STENOSIS DURING DEPLOYMENT. A SECOND ENTERPRISE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. INACCURATE PLACEMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF SELF EXPANDING STENTS AND IS LISTED IN THE ENTERPRISE IFU AS SUCH. 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. IN THIS CASE THE STENT WAS USED IN AN OFF LABEL MANOR WHICH CAN AFFECT THE EXPECTED FUNCTIONING OF THE DEVICE. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL AND LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING OFF-LABEL USED OF AN ENTERPRISE STENT TO TREAT A SYMPTOMATIC (MCA) MIDDLE CEREBRAL ARTERY STENOSIS, THE FIRST ENTERPRISE STENT MIGRATED DISTAL TO THE STENOSIS DURING DEPLOYMENT. A SECOND ENTERPRISE STENT WAS USED TO COMPLETE THE PROCEDURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention