BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1060058 · Received June 11, 2008

    Report

    Report Number
    2134265-2008-01662
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 26, 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

    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 BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 100% STENOSED, CHRONICALLY OCCLUDED, SEVERELY CALCIFIED TARGET LESION WAS IN THE SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 1.5X15MM APEX BALLOON CATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A 2.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) TO TREAT THE TARGET LESION, BUT THE DEVICE WOULD NOT ADEQUATELY CROSS THE LESION. THE PHYSICIAN MADE "SEVERAL" ATTEMPTS TO CROSS THE LESION WITH THE 2.5X16MM TAXUS EXPRESS2 DES BUT WAS UNSUCCESSFUL. UPON REMOVAL, A LIFTED STENT STRUT WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED 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 2.5X16MM 11416495

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR NAMIC INFLATION DEVICE| 6F TERUMO INTRODUCER| 6F LAUNCHER JL4 GUIDE CATHETER| RUNTHROUGH GUIDEWIRE