BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 597669 · Received April 28, 2005

    Report

    Report Number
    6000093-2005-00499
    Event Type
    Injury
    Date Received
    April 28, 2005
    Date of Event
    May 5, 2004
    Report Date
    May 6, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR# 6000093-2005-00500. 5 DAYS AFTER A DRUG ELUTING STENTING TREATMENT PROCEDURE, A SUB ACUTE THROMBOSIS (SAT) OCCURRED. THE PATIENT HAD TWO TAXUS DRUG ELUTING STENTS PLACED DUE TO AN ACUTE MYOCARDIAL INFARCTION. THE TAXUS EXPRESS2 8.8% 2.75X24MM ADN 2.75X8MM DRUG ELUTING STENTS WERE SUCCESSFULLY PLACED, TREATING A 90% STENOSED RIGHT CORONARY ARTERY (RCA). TWO DAYS LATER, THE PATIENT WAS TRANSFERRED TO ANOTHER STATION WITHIN HOSPITAL AND THE PLAVIX AND ASPIRIN WERE DISCONTINUED. FIVE DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT RETURNED TO THE CATH LAB. REPEAT ANGIOGRAPHY REVEALED A SAT IN THE RCA. IT IS UNONWN WHAT WAS DONE TO TREAT THE SAT. IN THE OPINION OF THE PHYSICIAN, THE SAT IS NOT RELATED TO THE TAXUS STRENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.75X24MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention