BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1191109 · Received September 26, 2008

    Report

    Report Number
    2134265-2008-02816
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENT PLACEMENT PROCEDURE, THAT DEPLOYMENT DIFFICULTIES AND A SHAFT BREAK OCCURRED. THE LESION BEING TREATED WAS A 90% STENOSIS LOCATED IN A TORTUOUS CAROTID ARTERY; THE ANATOMY LOCATION AND LESION CHARACTERISTICS ARE UNKNOWN. ANOTHER MANUFACTURER'S GUIDE WIRE WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH A 3MM STERLING BALLOON. THE PHYSICIAN WAS ABLE TO ACCESS THE LESION WITH THE 10.0 X 31MM WALLSTENT MONORAIL STENT DELIVERY SYSTEM (SDS) WITHOUT A PROBLEM, HOWEVER, WHILE ATTEMPTING TO DEPLOY THE STENT "GREAT RESISTANCE" WAS ENCOUNTERED. SOME MOVEMENT WAS ACHIEVED AT THE HANDLE OF THE STENT DELIVERY SYSTEM, HOWEVER, THE STENT DID NOT DEPLOY. AFTER SUCCESSFULLY REMOVING THE SDS A SHAFT BREAK WAS NOTED; HOWEVER, IT IS UNKNOWN WHEN THIS HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. ADD'L INTO REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC 10.0 X 31MM 0011515993

    Patients

    Seq Age Sex Outcome Treatment
    1 ABBOTT EMBOSHIELD FILTERWIRE