BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1202860 · Received October 17, 2008

    Report

    Report Number
    2134265-2008-03068
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5X15MM NON BSC DEVICE AND THEN THE 3.00X20MM TAXUS LIBERTE DRUG ELUTING STENT (DES) WAS ADVANCED TO THE LESION. THE TAXUS LIBERTE DEVICE WAS UNABLE TO CROSS THE LESION, AND WHEN THE DEVICE WAS WITHDRAWN FROM THE PT, IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE PHYSICIAN THEN RETRIEVED THE GUIDE CATHETER, AND THE STENT WAS FOUND ON THE TIP OF THE GUIDE CATHETER. AFTER PREDILATING THE LESION AGAIN, ANOTHER OF THE SAME DEVICE WAS IMPLANTED IN THE PROXIMAL LAD. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.00X20MM 11553724

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other