BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1101692 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02230
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    March 7, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. STENT THROMBOSIS IS A KNOWN COMPLICATION OF STENT IMPLANTATION WHICH HAS BEEN REPORTED FOR DRUG ELUTING STENTS. THE POTENTIAL ROOT CAUSES WERE REVIEWED. THE RESULT OF THIS REVIEW INDICATED THAT THE CURRENT MANUFACTURING PROCESS CONTROLS TO PREVENT THIS FAILURE FROM OCCURRING WERE DEEMED ADEQUATE. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS PARTICULAR TOP ASSEMBLY BATCH NUMBER FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    TAXUS EXPRESS2 CLINICAL STUDY. SAME CASE AS 2134265-2008-02236. IT WAS REPORTED THAT 2 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED A MYOCARDIAL INFARCTION (MI), STENT THROMBOSIS (ST) AND REQUIRED A TARGET VESSEL REINTERVENTION (TVR). LESION 1 WAS A 3.0MM, 90% STENOSED, 32MM LONG PORTION OF THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT A TAXUS EXPRESS2 3.00X32MM STUDY STENT IN THE TARGET LESION. POST DILATED WITH THE SAME BALLOON USED FOR PRE-DILATATION AND ANTHER BALLOON 2.75-15MM AT 20 ATM. LESION 2 WAS A 2.75MM, 90% STENOSED, 32 MM LONG PORTION OF THE MID RIGHT CORONARY ARTERY (MID RCA). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 2.75X32MM STUDY STENT IN THE TARGET LESION. POST DILATATION WAS NOT PERFORMED AND IT WAS CONFIRMED WITH IVUS AND THERE WERE NO REPORTED PROBLEMS. TWO DAYS AFTER THE INDEX PROCEDURE, THE PT EXPERIENCED A MI, ST AND REQUIRED A TVR. THE RCA WAS 100% STENOSED. PCI WAS PERFORMED AND IT WAS DILATED WITH BALLOON. CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE TAXUS STENT ARE POSSIBLY RELATED. THE PT WAS DISCHARGED 50 DAYS LATER. THE STENT WAS WITHDRAWN SURGICALLY AT THE TIME OF THE CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.00X32MM 11087381

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R