BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2170575 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02859
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE LIBERTE MONORAIL (MR) STENT DELIVERY SYSTEM WAS RETURNED WITH THE BALLOON TIGHTLY FOLDED WITH THE STENT IMPLANT SECURED BETWEEN THE MARKERBANDS. FOUR STRUTS IN THE FIRST PROXIMAL ROW AND THREE STRUTS IN THE SECOND PROXIMAL ROW WERE BENT BACK DISTALLY. THERE WAS NO OTHER DAMAGE TO THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY ANGIOPLASTY(PCI) STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS, PROXIMAL TO MID RIGHT CORONARY ARTERY. PRE-DILATION WITH A 2.5 X 20MM NON-BSC BALLOON WAS PERFORMED INFLATED TO 12ATM 3 TIMES. THE 3.0 X 24MM LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED SEVERAL TIMES WITHOUT CROSSING THE LESION. THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM AND NOTICED THAT THE DISTAL PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893824300 13380401

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO 6F| GUIDE WIRE: TERUMO RUNTHROUGH| GUIDE CATHETER: MEDTRONIC LAUNCHER 6F JR4| BALLOON CATHETER:TAZUNA 2.5-20