BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770040 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-07293
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    November 22, 2005
    Report Date
    November 22, 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 TREATMENT PROCEDURE A THROMBUS OCCURRED. TARGET LESION 1 WAS LOCATED IN THE CIRCUMFLEX ARTERY (CX). THE REFERENCE VESSEL DIAMETER WAS 3.2MM AND THE LESION LENGTH WAS 20MM. PRE-PROCEDURE THERE WAS 98% STENOSIS AND POST-PROCEDURE 0% STENOSIS. A 3.5X24MM LIBERTE STENT WAS IMPLANTED. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE THROMBUS. TARGET LESION 2 WAS LOCATED IN THE CX. THE REFERENCE VESSEL DIAMETER WAS 3.2MM AND THE LESION LENGTH WAS 18MM. PRE-PROCEDURE THERE WAS 78% STENOSIS AND POST-PROCEDURE 0% STENOSIS. A 3.5X24MM LIBERTE STENT WAS IMPLANTED. THE STENTING PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE INDEX PROCEDURE WITH NO ANGINAL COMPLAINTS OR SILENT ISCHEMIA. THE DISCHARGE MEDICATIONS WERE ASA 100MG PER DAY FOR 12 MONTHS, CLOPIDOGREL 75 MG/DAY FOR 12 MONTHS AND HEPARIN.

    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