BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770048 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-07311
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    June 20, 2006
    Report Date
    June 20, 2006
    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 IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DIRECTION FOR USE (DFU). (B)(4). DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE THROMBOSIS OCCURRED. A SINGLE LESION WAS IDENTIFIED IN THE RIGHT CORONARY ARTERY (RCA). THE REFERENCE VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 24MM. PRE-PROCEDURE THERE WAS 69% STENOSIS. DIRECT STENTING WAS NOT ATTEMPTED. A 3X32MM LIBERTE STENT WAS IMPLANTED. AN ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION; A THROMBECTOMY DUE TO THROMBUS. THE PROCEDURE WAS TECHNICALLY SUCCESSFUL. POST-PROCEDURE THERE WAS 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS AFTER THE INDEX PROCEDURE. THE PATIENT HAD NO ANGINAL COMPLAINTS OR SILENT ISCHEMIA. THE DISCHARGE MEDICATIONS WERE: ASA 100MG/DAY X 12 MONTHS AND CLOPIDOGREL 75MG/DAY X 12 MONTHS. THE SUBJECT DID NOT EXPERIENCE ANY MAJOR CARDIAC EVENTS.

    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 67 YR Required Intervention