BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770049 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-07315
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    September 15, 2006
    Report Date
    September 15, 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 TREATMENT PROCEDURE THROMBUS OCCURRED. TARGET LESION 1 WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND HAD A REFERENCE VESSEL DIAMETER OF 3.2MM. THE LESION LENGTH WAS 40MM WITH 60% STENOSIS. DIRECT STENTING WAS NOT ATTEMPTED AND A NON-BSC BALLOON WAS USED. A 3.5X32MM LIBERTE STENT WAS IMPLANTED. AN ADDITIONAL PROCEDURE WAS PERFORMED OF THE IMPLANT OF A SECOND LIBERTE STENT TO COVER THE ENTIRE LESION LENGTH AND DUE TO THROMBUS. THE PROCEDURE WAS TECHNICALLY SUCCESSFUL WITH A RESIDUAL STENOSIS OF 0%. TARGET LESION 2 WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND HAD A REFERENCE VESSEL DIAMETER OF 2.0MM. THE LESION LENGTH WAS 16MM WITH 73% STENOSIS. A LIBERTE 3.5X20MM WAS IMPLANTED. THE PROCEDURE WAS TECHNICALLY SUCCESSFUL WITH A RESIDUAL STENOSIS OF 20%. THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE INDEX PROCEDURE WITHOUT ANGINA OR SILENT ISCHEMIA. DISCHARGE MEDICATIONS WERE ASPIRIN 100MG AND CLOPIDOGREL 75MG DAILY FOR TWELVE 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 68 YR Required Intervention SPRINTER BALLOON CATHETER