BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1024307 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00960
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE FILTERWIRE KINKED, THE KINKED PART IS OUTSIDE OF THE SHEATH. THE PHYSICIAN CHOSE TO STILL USE IT. THERE WAS A LITTLE BIT DIFFICULTY ADVANCING THE STENT DELIVER SYSTEM TO THE TORTUOUS AND CALCIFIED RIGHT INTERNAL CAROTID ARTERY. THE 4-9X30MM NEXSTENT WAS DEPLOYED WITHOUT PROBLEM. WHEN PULLING OUT THE WHOLE STENT DELIVERY SYSTEM OUTSIDE OF THE BODY, THE PHYSICIAN FOUND THE INNER CATHETER SEPARATED FROM OUTER CATHETER. THERE WAS NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE PATIENT STATUS WAS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C72402

    Patients

    Seq Age Sex Outcome Treatment
    1