BEUDAMED
    FDA Adverse Event Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE

    MDR report key: 1844956 · Received September 22, 2010

    Report

    Report Number
    1844956
    Date Received
    September 22, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC
    Product Code
    NJE
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING NEURO STENTING PROCEDURE 28MM ENTERPRISE STENT DEPLOYED BY PHYSICIAN. UNDER FLUOROSCOPY ENTERPRISE STENT APPEARED TO BE SHORT. PACKAGING CHECKED AND FOUND 3 OF 4 LABELS READ 28MM AND ONE READ 22MM. PHYSICIAN FELT THAT PT NEEDED ADDITIONAL STENT TO COVER ANEURYSM. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE INTRACRANIAL NEUROVASCULAR STENT NJE CORDIS NEUROVASCULAR, INC * W1419796

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR