BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1161176 · Received September 15, 2008

    Report

    Report Number
    1058196-2008-00222
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 21, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS PATIENT WITH UNKNOWN WEIGHT WAS ADMITTED WITH A DIAGNOSIS OF CAROTID CAVERNOUS ANEURYSM AND MEDICAL HISTORY OF HEADACHES. THE ANATOMY WAS TORTUOUS, AND THE ANEURYSM NECK WAS 2.3 MM AND THE REST OF THE MEASUREMENT WAS 3.1MM X 2.5MM. DURING ASSISTED COIL EMBOLIZATION PROCEDURE, THE PT HAD A 22MM ENTERPRISE STENT PLACED IN THE CAVERNOUS CAROTID (2008), AND THE STENT PLACEMENT WENT SMOOTHLY ALTHOUGH THE PHYSICIAN WAS NOT ABLE TO NAVIGATE A MICRO-CATHETER THROUGH THE STRUTS TO COIL THE ANEURYSM. THE DECISION WAS MADE TO BRING BACK THE PT FOR COILING AFTER THE STENT HAD TIME TO ENDOTHELIALIZE. THE PT WAS BROUGHT BACK INTO THE LAB THREE MONTHS AFTER THE INDEX PROCEDURE FOR EMBOLIZATION WITH COILS. HOWEVER, THE PHYSICIAN WAS NOT ABLE TO NAVIGATE A MICRO-CATHETER THROUGH THE STRUTS. AFTER TAKING MORE IMAGES, WITH BOTH MR AND ANGIOGRAPHY, IT WAS DETERMINED THE STENT WAS KINKED. THE PT REMAINS STABLE BUT THE ANEURYSM MAY NOT BE ABLE TO BE TREATED DUE TO THE KINK IN THE STENT. DURING THE PROCEDURE, THE STENT WAS NOT RECAPTURED MORE THAN ONCE. DURING DEPLOYMENT, TORQUE WAS NOT APPLIED TO THE DELIVERY SYSTEM. DURING DETACHMENT, CONSTANT FLUOROSCOPY WAS PERFORMED, AND ALL (IFU) INSTRUCTION FOR THE GUIDELINES WAS FOLLOWED. DURING DETACHMENT, THE DELIVERY SYSTEM DID NOT MOVE FROM THE SITE. THE PT WAS PUT ON ANTIPLATELET THERAPY. THE LOT NUMBER CANNOT BE OBTAINED AT THIS TIME, SINCE IT WAS NOT LISTED IN THE CHART. FILMS WERE PROVIDED AND IS PENDING REVIEW REPORT.

    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 52 YR Hospitalization| R PROWLER MICROCATHETER