BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1231303 · Received October 27, 2008

    Report

    Report Number
    1058196-2008-00253
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    UPON RECAPTURE THEY NOTICED, THE STENT WAS CRUSHED. THE STENT WAS ORIGINALLY PLACED IN THE INTERNAL CAROTID ARTERY (ICA) AND POSITIONED FOR DEPLOYMENT. THE PHYSICIAN WANTED TO ADVANCE THE MICROCATHETER INTO THE MIDDLE CEREBRAL ARTERY (MCA), SO HE RE-SHEATHED AND REMOVED THE STENT FROM THE MICROCATHETER (MC). HE SAID HE EXAMINED THE STENT ON THE BACK TABLE TO BE SURE IT WAS SAFELY HOUSED IN THE SHEATH. HE THEN RE-INSERTED THE STENT INTO THE HUB OF THE MICROCATHETER AND FELT A LOT OF RESISTANCE AS HE TRIED TO ADVANCE THE STENT. HE THEN REMOVED THE STENT AND SAID THE PROXIMAL END WAS "CRUSHED". THE DISTAL END AND CENTER OF THE STENT WERE NOT DAMAGED. THIS TARGET LESION WAS ICA, TORTUOUS AND WIDE NECK. THE DIAMETER OF THE PARENT VESSEL WAS 3.7 AND DISTAL WAS 3.2. RESISTANCE FELT WHILE ADVANCING THE DELIVERY SYSTEM INTO THE PROWLER SELECT MC. CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE MC. THE STENT WAS BEING RECAPTURE TO REPOSITION AND NO DIFFICULTY WAS EXPERIENCED PLACING THE STENT. THE STENT AND DELIVERY SYSTEM REMOVED FROM THE MC. ANOTHER ENTERPRISE (SAME SIZE) WAS DEPLOYED THROUGH THE SAME PROWLER SELECT MC WITH NO PROBLEMS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    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 13443822

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROWLER SELECT MC