BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770041 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-07300
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    December 1, 2005
    Report Date
    December 1, 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 AS THIS COMPLAINT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN 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 DURING A CORONARY ARTERY TREATMENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE TARGET VESSEL REFERENCE DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 26MM. PRE-PROCEDURE STENOSIS WAS 100% AND POST-PROCEDURE WAS 2% STENOSIS. A 2.75X28MM LIBERTE STENT WAS IMPLANTED. NO INFORMATION IF DIRECT STENTING WAS ATTEMPTED. AN ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION DUE TO REMOVAL OF THROMBUS. THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED WITHOUT CURRENT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATION INCLUDED: 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 58 YR Required Intervention