BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1981498 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00090
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE STENT WAS NO LONGER PRESENT ON THE SDS. THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE BALLOON WAS IN A TIGHTLY FOLDED CONDITION AND MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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 STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES AND STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 90% STENOSED, 8X2.75MM, ECCENTRIC AND DENOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (CX). THE LESION WAS PREDILATED WITH A 2.0X15MM APEX BALLOON CATHETER AND THE RESIDUAL STENOSIS WAS 80%. AFTER ADVANCING A 16X2.5MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS), THE SYSTEM WAS PULLED BACK AND THERE WAS RESISTANCE. WHEN THE SDS WAS PULLED BACK INTO THE GUIDE CATHETER, THE STENT DISLODGED IN THE LEFT MAIN. THE STENT WAS CRUSHED AGAINST THE VESSEL WALL WITH A 3.0X12MM NON-BSC STENT. DURING THIS PROCEDURE, A 2.25X16MM TAXUS STENT WAS PLACED IN THE MID CX AND A 2.25X8MM TAXUS ATOM STENT WAS PLACED IN THE OSTIAL CX. THE LESION WAS POST DILATED WITH A 3.0X12MM NC QUANTUM BALLOON. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 - MAPLE GROVE H7493893616250 0013306060

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention 6F (EBU)3.5 GUIDE CATHETER| 2.0X15 APEX BALLOON CATHETER| PT GUIDE WIRE