BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2121089 · Received June 13, 2011

    Report

    Report Number
    2134265-2011-02163
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 16, 2011
    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

    (B)(4). 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 DURING A STENTING TREATMENT PROCEDURE, STENT MIGRATION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS IMAGED USING IVUS AND THEN A 4.00X12MM LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA AND THE STENT WAS DEPLOYED IN THE PROXIMAL RCA. FOLLOWING DEPLOYMENT IT WAS NOTED THAT NO STENT WAS VISUALIZED IN THE TARGET LOCATION USING ANGIOGRAPHY. PROCEDURE WAS COMPLETED WITH DEPLOYMENT OF A 4.0X9MM NON-BSC STENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812400 13490573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other