BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1192124 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02950
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE 95% STENOTIC DE NOVO LESION WAS LOCATED IN THE HEAVILY CALCIFIED AND MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN FIRST PREDILATED THE LESION WITH A 2.5X15MM AND 2.5X30MM BALLOON CATHETERS. THEN THE PHYSICIAN BEGAN INTRODUCING THE 4.0X16MM LIBERTE BARE STENT THROUGH A GUIDE CATHETER AND FELT RESISTANCE WHEN THE STENT WAS IN THE PROXIMAL PORTION OF THE RCA. THE PHYSICIAN THEN DECIDED TO REMOVE THE STENT AND SAW THAT THE STENT WAS IN THE GUIDING CATHETER LUMEN. THE PHYSICIAN REMOVED THE WHOLE SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 4.0X12MM LIBERTE BARE STENT. PT STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11752780

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other