BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1051694 · Received May 19, 2008

    Report

    Report Number
    2134265-2008-01436
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    February 6, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE SHOPFLOOR PAPERWORK FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, THE ROOT CAUSE OF THIS COMPLAINT WILL BE DOCUMENTED AS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURING SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. SAME CASE AS 2134265-2008-01437. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS OBSERVED. THE LESION BEING TREATED WAS A 2.0X17.4 MM, 70% STENOSED, CALCIFIED AND TORTUOUS PORTION OF THE DISTAL LEFT CIRCUMFLEX (DIST CX). BEFORE IMPLANTATION, THE LESION WAS PREDILATED WITH A 2.0 X 15 MM BALLOON (TYPE UNK) AT 10 ATM. AFTER THAT THE PHYSICIAN TRIED TO CROSS A TAXUS EXPRESS2 DRUG ELUTING STENT, BUT FAILED AS THE LESION WAS SEVERELY TORTUOUS. A SECOND TAXUS EXPRESS2 STENT ALSO FAILED TO CROSS THE LESION. BOTH STENT WAS NOTICED TO HAVE STRUT DAMAGE. FINALLY, A 2.5X16MM TAXUS EXPRESS2 WAS IMPLANTED SUCCESSFULLY. THERE WAS NO PATIENT COMPLICATIONS DURING THE PROCEDURE AND THE PATIENT STATUS WAS REPORTED AS "GOOD".

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR