BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3162314 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-04010
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED TIP DAMAGE. THE TIP WAS SLIGHTLY FLARED WHICH IS CONSISTENT WITH THE TIP ENCOUNTERING RESISTANCE UPON ADVANCEMENT DURING ATTEMPTS TO CROSS THE LESION. DISTAL STENT DAMAGE WAS PRESENT. THE STENT STRUTS ON DISTAL ROW 1 WERE LIFTED. THIS DAMAGE IS ALSO EVIDENCE OF THE STENT ENCOUNTERING AN OBSTRUCTION DURING ADVANCEMENT TO THE LESION. STENT STRUTS ON PROXIMAL ROW 1 WERE SLIGHTLY FLARED WHICH IS CONSISTENT WITH POSITIVE PRESSURE BEING APPLIED TO THE BALLOON. THE BALLOON WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. NO KINKS OR DAMAGE WERE NOTED ALONG THE SHAFT OF THE DEVICE. 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

    REPORTABLE BASED ON ANALYSIS APPROVED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING PROCEDURE, DIFFICULTY CROSSING THE LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 12MM 4.00 LIBERTÉ STENT DELIVERY SYSTEM WAS USED TO ADVANCE THE LESION AND COULD NOT CROSS THE LESION. HOWEVER, ANALYSIS FOUND DISTAL AND PROXIMAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262352 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893812400 14123355

    Patients

    Seq Age Sex Outcome Treatment
    1