BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770002 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06402
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    October 28, 2005
    Report Date
    October 28, 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. THIS COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN 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 THROMBOSIS OCCURRED. THE TARGET LESION #1 WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE TARGET VESSEL REFERENCE DIAMETER WAS 3MM AND THE LESION LENGTH WAS 30MM. PRE-PROCEDURE STENOSIS WAS 70%. POST-PROCEDURE WAS 0% STENOSIS. A LIBERTE STENT WITH A DIAMETER OF 3.5MM AND LENGTH OF 32MM WAS IMPLANTED. NO INFORMATION STATING IF DIRECT STENTING WAS ATTEMPTED. AN ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION FOR THROMBO ASPIRATION. THE PROCEDURE WAS A TECHNICAL SUCCESS. TARGET LESION #2 WAS LOCATED IN THE RCA. THE TARGET VESSEL REFERENCE DIAMETER WAS 3MM AND THE LESION LENGTH WAS 15MM. PRE-PROCEDURE STENOSIS WAS 65%. POST-PROCEDURE WAS 0% STENOSIS. A LIBERTE STENT WITH A DIAMETER OF 3.5MM AND LENGTH OF 16MM WAS IMPLANTED. NO INFORMATION STATING IF DIRECT STENTING WAS ATTEMPTED. THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED FIVE DAYS POST PROCEDURE WITHOUT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATION INCLUDES: 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 49 YR Hospitalization