BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1230214 · Received November 13, 2008

    Report

    Report Number
    2134265-2008-04340
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. TWO OVERLAPPING TAXUS EXPRESS2 3.0X16MM DRUG ELUTING STENTS WERE IMPLANTED IN UNKNOWN LESION. THE PATIENT CAME BACK 7 MONTHS LATER WITH RESTENOSIS. THE PHYSICIAN ATTEMPTED TO TREAT WITH AN APEX BALLOON 1.5X15MM, BUT HAD DIFFICULTIES CROSSING THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION WAS REQUESTED, BUT NOT RECEIVED FROM CUSTOMER.

    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 CORPORATION 3.00X16MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other