BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080940 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02074
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE 75% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS (ABOUT 90 DEGREES) AND NON-CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN FIRST PRE-DILATED THE LESION WITH A 3.5 X 15MM APEX BALLOON. THEN THE PHYSICIAN ADVANCED THE 3.50X20MM TAXUS EXPRESS2 STENT TO THE LESION AND TRIED TO CROSS THE LESION SEVERAL TIMES, BUT WAS UNABLE TO CROSS. DURING THE WITHDRAWAL OF THE STENT DELIVERY SYSTEM THE STENT DISLODGED AT THE OSTIUM OF THE CORONARY ARTERY. THE DISLODGED STENT WAS RETRIEVED FROM THE PT WITHOUT ANY INJURIES OR COMPLICATIONS. TREATMENT FOR THE LESION WAS POSTPONED TO A LATER DATE. PT CONDITION IS 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 3.50X20MM 11067634

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention