BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 708492 · Received May 3, 2006

    Report

    Report Number
    6000089-2006-00831
    Event Type
    Injury
    Date Received
    May 3, 2006
    Date of Event
    August 25, 2005
    Report Date
    April 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS 6000089-2006-0000827 AND 6000089-2006-00833. SEVENTEEN MONTHS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PT REQUIRED A TARGET VESSEL REINTERVENTION (TVR). LESION 1 WAS A 2.5MM, 90% STENOSED, 60 MM PORTION OF THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH IVUS AND DIRECT STENT PLACEMENT OF TWO TAXUS EXPRESS2 8.8% 2.50 X 24MM DRUG ELUTING STENTS WITH A 2MM OVERLAP. THE LESION WAS POST-DILATED. LESION 2 WAS A 3.0MM, 90%, 15MM LONG PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD). THE PHYSICIAN TREATED THE LESION WITH IVUS AND DIRECT STENT PLACEMENT OF A TAXUS EXPRESS2 8.8% 3.00 X 20MM DRUG ELUTING STENT IN THE TARGET LESION OVERLAPPING THE PREVIOUSLY PLACED STENTS BY 2MM. LESION 3 WAS A 2.5MM, 90% STENOSED, 10MM LONG PORTION OF THE 1ST DIAGONAL (1ST DX). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 2.50 X 12MM DRUG ELUTING STENT IN THE TARGET LESION. LESION 4 WAS A 4.0MM, 75% STENOSED, 20MM LONG PORTION OF THE MID RIGHT CORONARY ARTERY (MID RCA). THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A TAXUS EXPRESS2 8.8% 3.50 X 28MM DRUG ELUTING STENT IN THE TARGET LESION OVERLAPPING THE PREVIOUSLY PLACED STENTS BY 1MM. THE LESION WAS POST-DILATED. THE PT WAS DISCHARGED 2 DAYS LATER ON PLAVIX AND ASPIRIN. 17 MONTHS AFTER THE INITIAL PROCEDURE THE PT REQUIRED A TVR OF THE LAD. THE PHYSICIAN SUCCESSFULLY PLACED 2 JOHNSON & JOHNSON CYPHER STENTS IN THE PROX LAD. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE TVR TO THE TAXUS STENTS IS PROBABLE AND THERE WAS IN-STENT RESTENOSIS OF THE TAXUS STENTS. THE PT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC 2.50 X 24MM 6105760

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention