BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770030 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06735
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    July 13, 2005
    Report Date
    July 13, 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). SAME CASE AS 2134265-2009-06736 AND 2134265-2009-06796. IT WAS REPORTED THAT POST A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED AND POST INDEX PROCEDURE RE-INTERVENTION OCCURRED. TARGET LESION 1 WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE REFERENCE VESSEL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 22MM. PRE-PROCEDURE WAS 100% STENOSIS AND POST-PROCEDURE 2% STENOSIS. A 3.5X24MM LIBERTE STENT WAS IMPLANTED. NO ATTEMPT MADE FOR DIRECT STENTING. TARGET LESION 2 WAS LOCATED IN THE RCA. THE REFERENCE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 26MM. PRE-PROCEDURE WAS 80% STENOSIS AND POST-PROCEDURE WAS 2% STENOSIS. A 3.0X28MM LIBERTE STENT WAS IMPLANTED. NO ATTEMPT MADE FOR DIRECT STENTING. DUE TO A DISSECTION AN ADDITIONAL 3.0X16MM LIBERTE STENT WAS IMPLANTED. TARGET LESION 3 WAS LOCATED IN THE RCA. THE REFERENCE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 14MM. PRE-PROCEDURE WAS 82% STENOSIS AND POST-PROCEDURE WAS 2% STENOSIS. A 3.0X16MM LIBERTE STENT WAS IMPLANTED. NO ATTEMPT MADE FOR DIRECT STENTING. THE PROCEDURE WAS A TECHNICAL SUCCESS. AT 4 DAYS POST-PROCEDURE, THE PATIENT HAD RE-PTCA IN TARGET LESION 1 WITH 99% STENOSIS, VISUAL "OCCLUSION" AND A POSITIVE INVASIVE DIAGNOSTIC TEST. THE PATIENT WAS DISCHARGED 8 DAY POST INDEX PROCEDURE WITHOUT ANGINA COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATIONS INCLUDED ASA 100MG/DAILY 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 76 YR Required Intervention