BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1181234 · Received September 23, 2008

    Report

    Report Number
    1058196-2008-00225
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDEH60001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAY OF RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT # 1058196-2008-00224.

    Description of Event or Problem · 1

    THIS PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OF THE OPHTHALMIC ARTERY, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO PUT A 37MM ENTERPRISE STENT INTO A TORTUOUS SECTION OF THE CAROTID ARTERY/OPHTHALMIC ARTERY WITH A PARENT VESSEL DIAMETER OF 3MM, BUT HAD SOME DIFFICULTY ADVANCING THE E STENT. THE 37MM ENTERPRISE WAS RECAPTURE THREE TIMES, BECAUSE IT WAS DIFFICULT TO POSITION AT THE SITE. DURING THE THIRD REMOVAL, THE ENTERPRISE DELIVERY SYSTEM WAS STUCK INSIDE THE MICROCATHETER. THEREFORE, BOTH UNITS WERE REMOVED SIMULTANEOUSLY. AFTER, REMOVAL FROM THE PATIENT, A KINK WAS NOTED IN THE MICROCATHETER. ADDITIONALLY, APPARENTLY PART OF THE ISSUES WAS THAT THE ENTERPRISE STENT MIGHT HAVE BEEN TOO BIG FOR THE ANEURYSM. DURING DEPLOYMENT, ALL THE (IFU) INSTRUCTION FOR USE GUIDELINES WAS FOLLOWED. ADDITIONAL TORQUE WAS APPLIED TO THE ASSIST IN THE POSITIONING OF THE ENTERPRISE STENT. CONSTANT FLUSH AND FLUOROSCOPY WAS PERFORMED AT ALL TIMES. THE PATIENT RECEIVED ASPIRIN AND PLAVIX. BOTH UNITS WILL BE RETURNED FOR ANALYSIS. THE SYSTEM WAS PULLED OUT OF THE BODY AND A KINK WAS FOUND ON THE PROWLER CATHETER. THE STENT REMAINED IN THE CATHETER. HE THEN DECIDED TO USE A 28MM STENT IN THE SAME SPOT WITH A NEW PROWLER CATHETER. THE STENT DEPLOYED ON TARGET AND HE WAS ABLE TO COIL THE ANEURYSM WITH A GOOD RESULT. NO PATIENT HARM OR INJURY WAS REPORTED.

    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 13348247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROWLER MICROCATHETER