BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 601340 · Received May 9, 2005

    Report

    Report Number
    6000089-2005-00722
    Event Type
    Injury
    Date Received
    May 9, 2005
    Date of Event
    March 2, 2005
    Report Date
    April 18, 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

    SAME CASE AS MDR 6000089-2005-00723. THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 2.5 MM VESSEL DIAMETER, 75% STENOSED REGION OF THE MID LAD. THE PHYSICIAN PREDILATED THE LESION PRIOR TO SUCCESSFULLY PLACING TWO DRUG ELUTING STENTS INTO THE TARGET LESION. THE FIRST STENT PLACED WAS A TAXUS EXPRESS2 8.8% 2.5X24 MM (LOT 7118242) DRUG ELUTING STENT. THE SECOND STENT WAS A TAXUS EXPRESS2 8.8% 2.5X16 MM (LOT 7131671) DRUG ELUTING STENT. THE TWO DRUG ELUTING STENTS OVERLAPPED BY 10 MM AND WERE POST DILATED AFTER DEPLOYMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 1 DAY POST INDEX PROCEDURE RECEIVING ASA, AND PLAVIX. THE SITE REPORTED THAT THE PATIENT UNDERWENT A TARGET VESSEL REINTERVENTION OF THE MID LAD 55 DAYS POST INDEX PROCEDURE. THE PHYSICIAN TREATED THE TARGET LESION BY SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 DRUG ELUTING STENT INTO THE TARGET VESSEL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 1 DAY POST TVR.

    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 24MM 7118242

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention