BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1022602 · Received April 1, 2008

    Report

    Report Number
    2134265-2008-00937
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PROD 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 POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. IN 2005, THE PT PRESENTED TO THE CCL. THE 70% STENOSED, ECCENTRIC LESION WAS LOCATED IN A NON CALCIFIED AND NON TORTUOUS MID RIGHT CORONARY ARTERY. THE PHYSICIAN DIRECT STENTED WITH A TAXUS EXPRESS2 3.0X24MM DRUG ELUTING STENT, DEPLOYED AT 12 ATM'S FOR 20 SECONDS. THE STENT WAS POST DILATED WITH A 3.5X20MM QUANTUM MAVERICK BALLOON INFLATED TO 16 ATM'S FOR 20 SECONDS. IN 2008, THE PT RETURNED TO THE CCL WHERE THE TAXUS EXPRESS2 STENT WAS FOUND TO BE STENOSED. A 3.0X20MM QUANTUM MAVERICK BALLOON WAS USED WHICH "OPENED THE VESSEL NICELY". IT WAS THE PHYSICIAN'S OPINION, AFTER REVIEWING THE PROCEDURE INFORMATION, THAT THE STENT MAY NOT HAVE BEEN APPOSED TO VESSEL WALL AS WELL AS IT COULD HAVE BEEN. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    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 3.0X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention