BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770046 · Received July 25, 2010

    Report

    Report Number
    2134265-2010-00503
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    October 20, 2005
    Report Date
    October 20, 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 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 A DISSECTION OCCURRED. TARGET LESION 1 WAS IN THE RIGHT CORONARY ARTERY (RCA) WITH A 3.5MM REFERENCE VESSEL DIAMETER AND AN 18MM LESION LENGTH. PRE-PROCEDURE THERE WAS 53% STENOSIS AND POST-PROCEDURE 2% RESIDUAL STENOSIS. A 3.5X20MM LIBERTE STENT WAS IMPLANTED. TARGET LESION 2 WAS IN THE RCA WITH A 3.5MM REFERENCE VESSEL DIAMETER AND A 14MM LESION LENGTH. PRE-PROCEDURE THERE WAS 54% STENOSIS AND POST-PROCEDURE 6% RESIDUAL STENOSIS. A 3.5X16MM LIBERTE STENT WAS IMPLANTED. AN ATTEMPT MADE FOR DIRECT STENTING FAILED DUE TO STENOSIS. THERE WAS AN ADDITIONAL PROCEDURE FOR THIS TARGET LESION; A LIBERTE STENT WAS IMPLANTED TO TREAT A DISSECTION. THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE INDEX PROCEDURE WITH NO ANGINAL COMPLAINTS OR SILENT ISCHEMIA. THE DISCHARGE MEDICATIONS WERE ASA 100 MG/DAY FOR 12 MONTHS AND CLOPIDOGREL 75 MG/DAY 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 51 YR Required Intervention