BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 724871 · Received June 9, 2006

    Report

    Report Number
    6000089-2006-01149
    Event Type
    Injury
    Date Received
    June 9, 2006
    Date of Event
    February 13, 2006
    Report Date
    May 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT 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

    ARRIVE2 CLINICAL STUDY# 140-063. IT WAS REPORTED THAT 278 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 2.70MM, 95% STENOSED, MILDLY TORTUOUS, 9.0MM LONG PORTION OF THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 2.75X12MM DRUG ELUTING STENT IN THE TARGET LESION. THERE WERE NO REPORTED COMPLICATIONS. THE PT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. 278 DAYS AFTER THE INITIAL PROCEDURE THE PT REQUIRED A TVR OF THE MED LAD. THE PHYSICIAN PERFORMED BALLOON ANGIOPLASTY WITH RESOLUTION OF THE FOCAL 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.75X12MM 7296601

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention