BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1769943 · Received July 25, 2010

    Report

    Report Number
    2134265-2006-05832
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    August 29, 2005
    Report Date
    August 29, 2005
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 IS 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)(6) REGISTRY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, STENT DISPLACEMENT OCCURRED. THE TARGET VESSEL WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET VESSEL REFERENCE DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 8MM. PRE-PROCEDURE STENOSIS WAS 99% AND POST-PROCEDURE WAS 0% STENOSIS. A 3.5X12MM LIBERTE STENT WAS IMPLANTED. NO INFORMATION IF DIRECT STENTING WAS ATTEMPTED. ADDITIONAL STENTING WITH A LIBERTE STENT OCCURRED DUE TO STENT DISPLACEMENT. THE PROCEDURE WAS A TECHNICAL SUCCESS. PATIENT WAS DISCHARGED 2 DAYS LATER WITHOUT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATION INCLUDED ASPIRIN 75MG DAILY/ INDEFINITELY AND CLOPIDOGREL 75MG DAILY/12 MONTHS. HEPARIN AND LLB, IIA AGENT.

    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 70 YR Required Intervention