BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1203633 · Received October 16, 2008

    Report

    Report Number
    2134265-2008-03060
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTY OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE EXTREMELY TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS DILATED WITH A 1.5X15MM APEX BALLOON AND THEN WITH A 2.5X15MM NON BSC DEVICE. THE 2.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION BUT WAS UNABLE TO CROSS. THE PHYSICIAN TRIED TO REMOVE THE DEVICE, BUT WITHDRAWAL DIFFICULTIES OCCURRED. THE PHYSICIAN SLOWLY WITHDREW THE DEVICE AND WHEN THE DEVICE WAS COMPLETELY WITHDRAWN, IT WAS NOTICED THAT THE PROXIMAL SIDE OF THE WIRE EXIT PORT WAS STRETCHED. THE PROCEDURE WAS 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 2.50X16MM 11705998

    Patients

    Seq Age Sex Outcome Treatment
    1