BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3940830 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04142
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 23, 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 FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00MM X 28MM LIBERTÉ STENT WAS SELECTED AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT RESISTANCE. THE LESION WAS PRE-DILATED AGAIN WITH A NON-BSC BALLOON CATHETER. THE STENT WAS ADVANCED AGAIN BUT IT WAS ONLY ADVANCED UP TO THE MIDDLE OF THE LESION AND IT WAS REMOVED AGAIN FROM THE PATIENT. IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. AFTER THE PROCEDURE, IT WAS FOUND THAT A PART OF THE LESION HAD SUPERFICIAL CALCIFICATION. IT WAS CONSIDERED BY THE CUSTOMER THAT THE EVENT OCCURRED DUE TO CALCIFICATION ALONG WITH SEVERE STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418124 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893828400 14415208

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: SION| GUIDING CATHETER: LAUNCHER 7FR