BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1222516 · Received November 6, 2008

    Report

    Report Number
    1058196-2008-00264
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    May 1, 2008
    Report Date
    October 10, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE DEVICE IS AN UNKNOWN ENTERPRISE STENT. AS REPORTED IN 2008, ON-LINE EDITION OF THE NEUROSURGERY JOURNAL, A FEMALE PATIENT PRESENTED WITH SAH FROM ANOTHER ANEURYSM IN THE S/SUPRACLINOIDAL INTERNAL CAROTID ARTERY WITH A 4.3 MM PARENT VESSEL DIAMETER. THE PATIENT WAS TREATED WITH AN ENTERPRISE STENT AND MICROPLEX COILS (MICO VENTRION, ALISO VEIJO, CA). NAVIGATION OF THE COILING CATHETER WAS DIFFICULT DUE TO TORTUOSITY OF THE PARENT ARTERY AND DURING MANIPULATIONS, THE STENT MIGRATED. HOWEVER, IT REMAINED IN FRONT OF THE ANEURYSM NECK.

    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 69 YR MICROPLEX COILS (MICO VENTRION