BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172142 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02721
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 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 EVALUATION; 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 PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FAILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INTRODUCTION PHASE OF A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, TIP DETACHMENT OCCURRED. THE PHYSICIAN FELT A STRONG RESISTANCE WHILE INSERTING THE STENT DELIVERY SYSTEM (SDS) OF THE TAXUS EXPRESS2 2.5X8MM DRUG ELUTING STENT ONTO A GUIDEWIRE. UPON REMOVAL OF THE SDS THE PHYSICIAN NOTED THAT THE TIP OF THE CATHETER WAS DETACHED. THE DEVICE WAS NOT USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A TAXUS 2.5X12MM STENT. PT STATUS POST PROCEDURE IS NOTED 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 2.5X8MM 11577574

    Patients

    Seq Age Sex Outcome Treatment
    1