BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 819910 · Received February 16, 2007

    Report

    Report Number
    6000089-2007-00241
    Event Type
    Injury
    Date Received
    February 16, 2007
    Date of Event
    July 10, 2006
    Report Date
    January 19, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND THE DELIVERY DEVICE HAS BEEN DISPOSED, THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE SHOPFLOOR PAPERWORK FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED WITH THIS COMPLAINT INCIDENT.

    Description of Event or Problem · 1

    CLINICAL STUDY: SAME CASE AS 6000093-2007-00347. IT WAS REPORTED THAT 549 DAYS AFTER THE CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT REQUIRED A CORONARY ARTERY BYPASS GRAFTING (CABG). THE PATIENT WAS TREATED WITH A STAGED PROCEDURE. IN THE FIRST PROCEDURE THE LESION BEING TREATED WAS A 3.0MM, 90% STENOSED, 8MM PORTION OF THE DISTAL CIRCUMFLEX (DIST CX). THE PHYSICIAN TREATED THE LESION WITH PREDILATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 3.00X12MM STUDY STENT IN THE TARGET LESION. THE PATIENT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. SIX DAYS LATER THE PATIENT UNDERWENT THE NEXT PROCEDURE. THE LESION BEING TREATED WAS A 3.0MM, 75% STENOSED, 12MM LONG PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A 3.00X 16MM STUDY STENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. AT 549 DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT REQUIRED CABG OF OF THE 1ST OM, R-PDA AND DIST LAD. THE PATIENT WAS DISCHARGED 16 DAYS LATER. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE TVR TO THE TAXUS STENTS IS PROBABLE.

    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 3.00X16MM 7184231

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R