BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3782096 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02263
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 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.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). AFTER PLAIN OLD BALLOON ANGIOPLASTY (POBA), A 4.00MM X 16MM LIBERTÉ STENT WAS ADVANCED TO THE TARGET LESION HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT WITHOUT RESISTANCE AND UPON INSPECTION, IT WAS NOTICED THAT THE BALLOON TIP AND DISTAL END OF THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A 4.0MM X 15MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260625 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816400 16119212

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: LAUNCHER 7F