BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031597 · Received March 28, 2011

    Report

    Report Number
    2134265-2011-00844
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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, STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 90% STENOSED, 14X2.25-2.5MM, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PROXIMAL OBTUSE MARGINAL (OM) BRANCH. THE LESION WAS PREDILATED WITH A 1.5X12MM APEX BALLOON AND THE STENOSIS WAS REDUCED TO 70%. A 16X2.25MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT IT WAS UNABLE TO PASS THROUGH A PREVIOUSLY PLACED UNKNOWN STENT IN THE CIRCUMFLEX (CX). THE TAXUS LIBERTE SDS WAS PULLED BACK AND THE STENT DISLODGED. IT WAS NOT POSSIBLE TO VISUALIZE THE STENT UNDER FLUOROSCOPY. SEVERAL BALLOON INFLATIONS WERE PERFORMED IN THE TARGET LESION WHERE THE STENT MAY HAVE DISLODGED AND PER THE PHYSICIAN, THE DISLODGED STENT WAS CRUSHED BY BALLOON INFLATIONS. TO COMPLETE THE PROCEDURE, A 2.5X15 PROMUS STENT AND A 2.25X15 TAXUS ATOM STENT WERE PLACED IN THE CX. ALSO, A 2.25X14MM NON-BSC STENT WAS PLACED IN THE OM. NO ADDITIONAL PATIENT COMPLICATIONS OCCURRED AND THE PATIENT'S STATUS IS FINE.

    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 H7493893616220 13850231

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 7 FENCH MACH CLS 3.00 GUIDE CATHETER| PROWATER GUIDE WIRE| 1.5X12 APEX BALLOON CATHETER