BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1061941 · Received June 16, 2008

    Report

    Report Number
    2134265-2008-01682
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: 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 PROD 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, A SHAFT FRACTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS CIRCUMFLEX (CX). THE PHYSICIAN USED AN EXTRA LONG SHEATH DUE TO THE TORTUOSITY OF THE LESION. THE SHAFT STRAIGHTENED OUT THE LESION, BUT THE SHAFT OF THE 3.00 X 8 MM TAXUS EXPRESS2 DRUG ELUTING STENT BROKE IN HALF. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN CATHETER SUCCESSFULLY AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THE PT CONDITION IS LISTED AS OKAY.

    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 CORPORATION 3.00X8MM 11350090

    Patients

    Seq Age Sex Outcome Treatment
    1