BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 585138 · Received March 24, 2005

    Report

    Report Number
    6000093-2005-00355
    Event Type
    Injury
    Date Received
    March 24, 2005
    Date of Event
    January 24, 2005
    Report Date
    February 25, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS # 6000093-2005-00354. 3 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PT EXPERIENCED A REINTERVENTION. THE LESION BEING TREATED WAS A 2.5MM 99% STENOSED MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY. THE LESION WAS PREDILATED. THE PHYSICIAN THEN PLACED A TAXUS EXPRESS2 8.8% 2.50X24MM DRUG ELUTING STENT IN THE MID LAD. A DISSECTION OCCURRED DISTAL TO THE LESION. THERE WAS REPORTED TO BE A VISIBLE THROMBI THAT WAS TREATED AT THE SITE. THE NEXT LESION BEING TREATED WAS A 2.5MM 99% STENOSED DISTAL LEFT ANTERIOR DESCENDING (DIST LAD) ARTERY. THE LESION WAS PREDILATED. THEN THE PHYSICIAN PLACED A TAXUS EXPRESS2 8.8% 2.50X20MM DRUG ELUTING STENT IN THE DIST LAD. IT WAS REPORTED THAT THERE WAS A THROMBUS PRESENT. IN 2005 A REINTERVENTION OCCURED. THE MID LAD HAD A REINTERVENTION AND AN EXPRESS2 BARE METAL STENT WAS PLACED. THE PT WAS DISCHARGED IN THE 2ND DAY ON PLAVIX AND ASPIRIN. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE REINTERVENTION TO THE TAXUS STENT IS "PROBABLE". IN THE OPINION OF THE PHYSICIAN THERE WAS "NO RESTENOSIS".

    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% 2.50 X 20 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention