BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770016 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06390
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    February 5, 2006
    Report Date
    February 5, 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 CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATIONS. THIS COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE. (B)(4). DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) STENTING PROCEDURE, A RE-PTCA OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING. THE TARGET VESSEL REFERENCE DIAMETER WAS 3.3MM AND THE LESION LENGTH WAS 16MM. PRE-PROCEDURE WAS 61% STENOSIS AND POST-PROCEDURE WAS 0% STENOSIS. A 3.5X16MM LIBERTE STENT WAS IMPLANTED. NO INFORMATION IF DIRECT STENTING WAS ATTEMPTED. THE PROCEDURE WAS A TECHNICAL SUCCESS. THAT SAME DAY A RE-PTCA OF THE TARGET VESSEL WAS PERFORMED. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITHOUT CURRENT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATIONS 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 57 YR Required Intervention