BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770029 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06746
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    July 27, 2005
    Report Date
    July 27, 2005
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS COMPLAINT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DIRECTIONS FOR USE. (B)(4): DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE TARGET VESSEL REFERENCE DIAMETER WAS 2.8MM AND THE LESION LENGTH WAS 30MM. PRE-PROCEDURE STENOSIS WAS 100% AND POST-PROCEDURE WAS 0% STENOSIS. A LIBERTE STENT WITH A DIAMETER OF 3MM AND LENGTH OF 32MM WAS IMPLANTED. AN ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION DESCRIBED AS THROMBO ASPIRATION. THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED FIVE DAYS POST PROCEDURE WITHOUT CURRENT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATION INCLUDED: ASA 100MG AND CLOPIDOGREL 75MG DAILY FOR 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC IRELAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other