BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3910655 · Received July 2, 2014

    Report

    Report Number
    2134265-2014-03795
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). A 4.00MM X 16MM LIBERTÉ STENT WAS ADVANCED BUT WOULD NOT CROSS THE DISTAL PORTION OF THE PROXIMAL RCA. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE DISTAL PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387215 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816400 14468345

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: 6FR HEARTRAIL (TERUMO)| BALLOON CATHETER: LACROSSE NSE 3.75 X 13 (GOODMAN)| GUIDE WIRE: 0.014 INCH SION (ASAHI INTECC)