BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 681182 · Received February 27, 2006

    Report

    Report Number
    6000093-2006-00203
    Event Type
    Injury
    Date Received
    February 27, 2006
    Date of Event
    October 21, 2005
    Report Date
    January 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARRIVE2 CLINICAL STUDY #124-008 341 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PT REQUIRED A TARGET VESSEL REINTERVENTION (TVR) THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS A 3.5MM, 99% STENOSED PORTION OF A SAPHENOUS VEIN GRAFT LOCATED IN THE 1ST DIAGONAL (1ST DX). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXRESS2 8.8% 3.50X12MM DRUG ELUTING STENT IN THE TARGET LESION. THERE WERE NO COMPLICATIONS. THE PT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. 341 DAYS AFTER THE INITIAL PROCEDURE THE PT REQUIRED A TVR OF THE DX. THE PHYSICIAN PREFORMED BALLOON ANGIOPLASTY TO RESOLVE IN-STENT RESTENOSIS. THE PT WAS DISCHARGED THE NEXT DAY. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE TVR TO THE TAXUS STENT IS PROBABLE AND THERE WAS RESTENOSIS OF THE TAXUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.50X12 6790873

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention