BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2052528 · Received April 13, 2011

    Report

    Report Number
    2134265-2011-01137
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION REVEALED STENT DAMAGE. STRUT ROWS ON THE STENT WERE RAISED IN ONE AREA AND STRUT ROWS ON THE STENT WERE SQUASHED IN ANOTHER AREA. THE STENT OD MEASUREMENTS WERE WITHIN SPECIFICATION. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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

    REPORTABLE BASED ON PRODUCT ANALYSIS COMPLETED ON (B)(4) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PRE-DILATATED WITH A 2.5X15 MAVERICK BALLOON CATHETER. THE 28 X 2.75MM TAXUS LIBERTE MONORAIL STENT DELIVERY SYSTEM WAS ADVANCED. HOWEVER, DUE TO THE HEAVY CALCIFICATION THE STENT COULD NOT CROSS THE LESION. THE LIBERTE STENT DELIVERY SYSTEM WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894028270 13022282

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR