BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770031 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06443
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    October 26, 2005
    Report Date
    October 26, 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. THIS COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE.(B)(4) : DEVICE NOT AVAILABLE FOR ANALYLSIS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. TARGET LESION #1 WAS LOCATED IN THE LEFT ANTERIOR ARTERY (LAD). THE TARGET VESSEL REFERENCE DIAMETER WAS 3.1MM AND THE LESION LENGTH WAS 24MM. PRE-PROCEDURE STENOSIS WAS 97% AND POST-PROCEDURE WAS 0% STENOSIS. A LIBERTE STENT WITH A DIAMETER OF 3.5MM AND LENGTH OF 28MM WAS IMPLANTED. DIRECT STENTING WAS NOT ATTEMPTED. AN ADDITIONAL PROCEDURE WAS PERFORMED, REPORTED AS THROMBO ASPIRATION. THE PROCEDURE WAS A TECHNICAL SUCCESS. TARGET LESION #2 WAS LOCATED IN THE LAD. THE TARGET VESSEL REFERENCE DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 13MM. PRE-PROCEDURE STENOSIS WAS 70% AND POST-PROCEDURE WAS 0% STENOSIS. A LIBERTE STENT WITH A DIAMETER OF 2.75MM AND LENGTH OF 16MM WAS IMPLANTED. NO INFORMATION STATING IF DIRECT STENTING WAS ATTEMPTED. THE PROCEDURE WAS A TECHNICAL SUCCESS. TARGET LESION #3 WAS LOCATED IN THE LAD. THE TARGET VESSEL REFERENCE DIAMETER WAS 3.1MM AND THE LESION LENGTH WAS 12MM. PRE-PROCEDURE STENOSIS WAS 72% AND POST-PROCEDURE WAS 0% STENOSIS. A LIBERTE STENT WITH A DIAMETER OF 3.5MM AND LENGTH OF 16MM WAS IMPLANTED. NO INFORMATION STATING IF DIRECT STENTING WAS ATTEMPTED. THE PROCEDURE WAS A TECHNICAL SUCCESS. PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE WITHOUT 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 69 YR Other