BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770001 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06285
    Event Type
    Death
    Date Received
    July 25, 2010
    Date of Event
    February 1, 2006
    Report Date
    February 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DIRECTION FOR USE (DFU). (B)(4). DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4).IT WAS REPORTED THAT POST A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE REFERENCE VESSEL DIAMETER WAS 3.0MM AND THE LESION LENGTH WAS 20MM. PRE-PROCEDURE THERE WAS 100% PERCENT STENOSIS. DIRECT STENTING WAS NOT ATTEMPTED DUE TO RESIDUAL STENOSIS. A NON-BSC BALLOON WAS USED. CROSSING FAILURE OCCURRED RELATED TO CALCIFICATION. A 3.0X16MM LIBERTE STENT WAS IMPLANTED. THERE WAS SUBOPTIMAL DEPLOYMENT OF THE STENT. RESIDUAL STENOSIS WAS 50%.THE PATIENT WAS DISCHARGED FOUR DAYS LATER WITHOUT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. THE DISCHARGE MEDICATION WAS HEPARIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-CARDIAC DEATH ON THE DAY OF DISCHARGE. NO FURTHER DATA WAS PROVIDED REGARDING THE PATIENT'S DEATH.

    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 Death AQUA BALLOON CATHETER