BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2083328 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01785
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DETAILED EXAMINATION OF THE TIP AND WIRE LUMEN IDENTIFIED NO ISSUES. A 0.015INCH SIZE MANDREL WAS INSERTED THROUGH THE TIP AND WIRE LUMEN WITH NO RESTRICTIONS NOTED. THE STENT WAS UNIFORMLY CRIMPED ONTO THE BALLOON. DEVICE ANALYSIS DETERMINED THAT NO ISSUES WERE NOTED WITH THE RETURNED DEVICE WHICH COULD CONTRIBUTE TO THE COMPLAINT INCIDENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDE WIRE. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 28X3.5MM, ECCENTRIC AND DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. THE 28X3.50MM LIBERTE BARE STENT DELIVERY SYSTEM (SDS) BECAME STUCK TO THE 6 FRENCH NON-BSC GUIDE WIRE DURING INTRODUCTION. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT AND THERE WAS DIFFICULTY SEPARATING THE WIRE FROM THE SDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME WIRE AND A 28X3.50MM NON-BSC BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDE WIRE. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 28X3.5MM, ECCENTRIC AND DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. THE 28X3.50MM LIBERTE BARE STENT DELIVERY SYSTEM (SDS) BECAME STUCK TO THE 6 FRENCH NON-BSC GUIDE WIRE DURING INTRODUCTION. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT AND THERE WAS DIFFICULTY SEPARATING THE WIRE FROM THE SDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME WIRE AND A 28X3.50MM NON-BSC BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893828350 13676745

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW GUIDE WIRE