BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 596929 · Received April 27, 2005

    Report

    Report Number
    6000093-2005-00484
    Event Type
    Injury
    Date Received
    April 27, 2005
    Date of Event
    January 6, 2005
    Report Date
    March 28, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO TARGET LESIONS WERE TREATED DURING THE INDEX PROCEDURE. TARGET LESION 1 WAS A 4 MM VESSEL DIAMETER, 95% STENOSED REGION OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED THE LESION PRIOR TO SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 3.0X32 MM (LOT 6150151) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 2 WAS A 3.25 MM VESSEL DIAMETER, 75% STENOSED OSTIAL REGION OF THE PROXIMAL RCA. THE PHYSICIAN PREDILATED THE LESION PRIOR TO SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 3.5X16 MM (LOT 6161129) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. THE PT WAS DISCHARGED FROM THE HOSP 1 DAY POST INDEX PROCEDURE RECEIVING LIPITOR, PLAVIX, AND ASA. THE SITE REPORTED THAT 260 DAYS AFTER THE INDEX PROCEDURE THE PT UNDERWENT A TARGET VESSEL REINTERVENTION. ADDITIONAL INFO HAS BEEN REQUESTED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THIS EVENT WAS NOT RELATED TO THE INDEX PRO EDURE TAXUS STENT. PLEASE DISREGARD MDR 6000093-2005-00484

    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% 3.00 X 32 MM 6150151

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention