BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231068 · Received October 30, 2008

    Report

    Report Number
    2134265-2008-04144
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 15, 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 VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. THREE STRUTS ON THE FIRST STENT ROW FROM THE PROXIMAL EDGE WERE RAISED DISTALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED IN 2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. THE LESION WAS AN 80% STENOSED, SEVERELY CALCIFIED LESION LOCATED IN THE VERY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO IMPLANT A TAXUS LIBERTE' 2.25X24MM DRUG ELUTING STENT WITH DIRECT STENTING. THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION. PATIENT STATUS IS GOOD. HOWEVER, THE RETURNED PRODUCT REVEALED 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 2.25X24MM 11807009

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR