BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1052506 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01486
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED RIGHT CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE TAXUS EXPRESS2 2.5X16MM DRUG ELUTING STENT, HOWEVER, THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN PREDILATED WITH A 2.5X12MM QUANTUM MAVERICK BALLOON AND PLACED ANOTHER 2.5X16MM TAXUS EXPRESS2 STENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    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 2.5X16MM 11255522

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR