BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1111635 · Received August 13, 2008

    Report

    Report Number
    2134265-2008-02309
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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 DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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, STENT DAMAGE OCCURED. THE 99% STENOSED LESION IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX (LCX). THE PHYSICIAN PREDILATED THE LESION AND ATTEMPTED TO IMPLANT A TAXUS EXPRESS2 2.50X24MM DRUG ELUTING STENT. HOWEVER, THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION AND THE PHYSICIAN NOTED THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE PHYSICIAN PREDILATED THE LESION AGAIN AND COMPLETED THE PROCEDURE WITH ANOTHER TAXUS EXPRESS 2 DRUG ELUTING STENT. NO PT COMPLICATIONS OCCURRED AND PT STATUS AFTER PROCEDURE IS 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 CORPORATION 2.50X24MM 11500815

    Patients

    Seq Age Sex Outcome Treatment
    1