BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2032820 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01019
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: (B)(6). (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. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS HIGH LATERAL BRANCH. THE LESION WAS PREDILATED WITH A 10X2.5MM NON-BSC BALLOON. NEXT, A 20X2.5MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NON-BSC GUIDE CATHETER WITH DIFFICULTY. THE SDS WAS REMOVED BY PULLING THE STENT BACK INTO THE GUIDE CATHETER. DURING REMOVAL THE STENT DISLODGED IN THE MID SECTION OF THE GUIDE CATHETER. THE GUIDE CATHETER, TAXUS LIBERTE SDS AND STENT WERE REMOVED TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 H7493893620250 13037204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCORE FLEX 10-2.5MM| SION BLUE GUIDE WIRE| NEICH UBS 4.0 GUIDE CATHETER| TERUMO 6F SHEATH