BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1133086 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02423
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 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 ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED, CALCIFIED, TARGET LESION WAS IN THE EXTREMELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED TYPE OF 2.5MM BALLOON. THE PHYSICIAN ATTEMPTED TO ADVANCE AN UNSPECIFIED SIZE NON-BSC DRUG ELUTING STENT (DES) TO THE TARGET LESION, BUT THE DEVICE WOULD NOT CROSS THE LESION. THE PHYSICIAN THEN ADVANCED A 3.0X12MM TAXUS EXPRESS2 DES TO THE TARGET LESION, BUT THIS DEVICE WOULD ALSO NOT ADEQUATELY CROSS THE LESION. UPON REMOVAL, IT WAS NOTICED THAT THE PROXIMAL "SIDE" OF THE 3.0X12MM TAXUS EXPRESS2 DES APPEARED "LIFTED UP." THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION 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 3.0X12MM 11606188

    Patients

    Seq Age Sex Outcome Treatment
    1 CYPHER