BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770019 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06744
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    March 6, 2006
    Report Date
    March 6, 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 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 CORONARY ARTERY STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. TARGET LESION #1 WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE TARGET VESSEL REFERENCE DIAMETER WAS 3.2MM AND THE LESION LENGTH WAS 30MM. PRE-PROCEDURE STENOSIS WAS 97% AND POST-PROCEDURE WAS 4% STENOSIS. DIRECT STENTING WAS ATTEMPTED. A NON BSC BALLOON WAS USED. A LIBERTE STENT WITH A DIAMETER OF 3.5MM AND LENGTH OF 32MM WAS IMPLANTED. RESIDUAL STENOSIS WAS DOCUMENTED. AN ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION FOR THROMBO ASPIRATION. THE PROCEDURE WAS A TECHNICAL SUCCESS. ADDITIONALLY, TWO LESIONS OF THE RCA WERE SUCCESSFULLY TREATED DURING THIS PROCEDURE. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE 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 50 YR Other SPRINTER BALLOON CATHETER