BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 599085 · Received May 4, 2005

    Report

    Report Number
    6000093-2005-00532
    Event Type
    Injury
    Date Received
    May 4, 2005
    Date of Event
    December 2, 2004
    Report Date
    April 5, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 247 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PT UNDERWENT A TARGET VESSEL REINTERVENTION (TVR) OF THE MID RIGHT CORONARY ARTERY (RCA). THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 4.5 MM VESSEL DIAMETER, 95% STENOSED OSTIAL REGION OF THE MID RCA ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH AN ANGIOPLASTY BALLOON, AND A CUTTING BALLOON. ONE TAXUS EXPRESS2 8.8% 3.5X32MM (LOT 6171788) DRUG ELUTING STENT WAS SUCCESSFULLY PLACED WITHOUT COMPLICATION. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. THE PT WAS DISCHARGED FROM THE HOSP 1 DAY POST INDEX PROCEDURE RECEIVING PLAVIX. THE SITE REPORTED THAT THE PT UNDERWENT A TVR OF THE MID RCA ARTERY 247 DAYS POST INDEX PROCEDURE TO ALLEVIATE FOCAL IN-STENT RESTENOSIS. THE PHYSICIAN TREATED THE LESION BY SUCCESSFULLY PLACING ONE UNK BARE METAL STENT INTO THE TARGET VESSEL. THE PT WAS DISCHARGED FROM THE HOSP 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% 3.50 X 32 MM 6171788

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention