BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 615867 · Received June 21, 2005

    Report

    Report Number
    1016427-2005-00166
    Event Type
    Injury
    Date Received
    June 21, 2005
    Date of Event
    June 3, 2005
    Report Date
    June 21, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS ILLAC ARTERY ANGIOPLASTY (VESSEL DIAMETER WAS 9MM X LESION LENGTH 7CM). THE LESION WAS MODERATELY CALCIFIED WITH NO VESSEL TORTUOUSITY, AND THIS WAS FIRST TIME TREATMENT OF THIS ARTERY/LESION. A SMART CONTROL STENT WAS SELECTED FOR THE PROCEDURE. THERE WERE NO DAMAGES OF THE DEVICE OUT OF ITS PACKAGING AND NO PREPPING DIFFICULTY. HOWEVER, IT WAS REPORTED DURING THE PROCEDURE, THE STENT SYSTEM'S DELIVERY SHEATH BROKE, AN THE STENT REMAINED INSIDE THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN SHEATH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN SHEATH WITH A GOOSENECK SNARE. IT IS UNKNOWN IF THIS REMOVAL ATTEMPT WAS SUCCESSFUL. THIS EVENT WAS REPORTED TO BE LIFE THREATENING AND PROLONGED THE PROCEDURE FO 90 MINUTES. HOWEVER, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS FGE CORDIS DE MEXICO NA 40103185

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R