BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ?

    MDR report key: 4863764 · Received June 23, 2015

    Report

    Report Number
    2134265-2015-03886
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 28, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A LIBERTE STENT DELIVERY SYSTEM (SDS). THE BALLOON WAS LOOSELY FOLDED. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED BETWEEN THE MARKERBANDS AND SECURED TO THE BALLOON IN MANUFACTURING. THE STENT WAS NOT RETURNED FOR ANALYSIS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 STENT DISLODGMENT AND EMBOLIZATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.00MM X 8MM LIBERTÉ¿ STENT WAS ADVANCED TO THE LESION; HOWEVER, THE STENT WAS DETACHED FROM THE STENT DELIVERY SYSTEM BALLOON. THE DETACHED STENT THEN MOVED TO THE PROXIMAL PORTION OF THE LESION. THE STENT WAS SNARED AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406803 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H749389388300 15625731

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention