BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1213717 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03102
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF RELEASE TO DISTRIBUTION. FOLLOWING DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. STRUTS ON STENT ROWS ONE TO THREE FROM THE PROXIMAL EDGE WERE MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE SEVERELY CALCIFIED, 90% STENOSED LAD (LEFT ANTERIOR DESCENDING) LESION. NO PT INJURIES OR COMPLICATIONS WERE REPORTED AND THE PT WAS REPORTED TO BE "GOOD". HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.0X20MM 11550228

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR