BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1220283 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04174
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND CALCIFIED FIRST DIAGONAL OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION BUT WAS UNABLE TO CROSS THE PROXIMAL TO MID LAD. THE TAXUS EXPRESS2 DEVICE WAS REMOVED FROM INSIDE THE PT AND IT WAS NOTICED THAT THE PROXIMAL PORTION OF THE STENT WAS LIFTED UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.50X20MM 11781984

    Patients

    Seq Age Sex Outcome Treatment
    1