BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1276737 · Received December 30, 2008

    Report

    Report Number
    2134265-2008-05001
    Event Type
    Injury
    Date Received
    December 30, 2008
    Date of Event
    August 29, 2008
    Report Date
    December 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. TAKING INTO CONSIDERATION THE THOROUGH EVALUATION CONDUCTED AT THE CIS AND THE DETAILS OF THE COMPLAINT, THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLY ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2134265-2008-05000. IT WAS REPORTED THAT 294 DAYS AFTER A CORONARY ARTERY STENTING PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS AND REQUIRED REPEAT ANGIOGRAPHY. THE LESION BEING TREATED WAS A 2.50MM, 90% STENOSED, 30.0MM LONG PORTION OF THE DISTAL LEFT ANTERIOR DESCENDING (DIST LAD). THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION WITH A 2.25X15MM BALLOON AT MAXIMUM 10ATM. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO TAXUS EXPRESS2 STUDY STENTS (2.50X20MM AND 3.0X12MM) IN THE TARGET LESION IN AN OVERLAPPING FASHION. THESE STENTS WERE POST-DILATED BY 2.50X15MM BALLOON AT MAXIMUM 22ATM. POST-IVUS WAS PERFORMED. THESE STENTS WERE POSITIONED AND WELL EXPANDED (POST-% OF STENOSIS: 0% / TIMI FLOW: 3 / GAP: NO). THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE PATIENT DISCHARGED FROM THE HOSPITAL THE NEXT DAY. ABOUT 294 DAYS AFTER THE INDEX PROCEDURE, FOLLOW UP CORONARY ANGIOGRAPHY WAS PERFORMED. RESTENOSIS IN THE DIST LAD WAS CONFIRMED. BALLOON ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE RESTENOSIS TO THE TAXUS STENT IS POSSIBLY.

    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 CORPORATION 3.00X12MM 9449795

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R