BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1161313 · Received September 11, 2008

    Report

    Report Number
    2134265-2008-02617
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE 90% STENOSED, MILDLY CALCIFIED LESION WAS LOCATED AT THE POSTERIOR DESCENDING LEFT CIRCUMFLEX (LCX). THE PHYSICIAN PRE-DILATED THE LESION WITH A NON BSC BALLOON. AFTER THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 2.50X20MM DRUG ELUTING STENT, HE EXPERIENCED BALLOON WITHDRAWAL RESISTANCE. THE PHYSICIAN REPEATEDLY INFLATED AND DEFLATED AT NOMINAL PRESSURE SEVERAL TIMES, AND THEN SUCCESSFULLY REMOVED THE BALLOON. THERE WERE NO PT COMPLICATIONS AND THE PT STATUS AFTER PROCEDURE WAS 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 CORPORATION 2.50X20MM 11263711

    Patients

    Seq Age Sex Outcome Treatment
    1 VOYAGER BALLOON-2.0MM