BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1212643 · Received October 24, 2008

    Report

    Report Number
    2134265-2008-03520
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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 DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL DIFFICULTY, BLOOD CLOT, AND A DISSECTION OCCURRED. THE 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MILDLY TORTUOUS MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.5X20MM MAVERICK BALLOON. THE PHYSICIAN DEPLOYED A 2.75X28MM TAXUS EXPRESS2 DRUG ELUTING STENT, INFLATED TO 14 ATM FOR 40 SECONDS. STENT WAS IMPLANTED SUCCESSFULLY. THEN STENT DELIVERY BALLOON WAS DEFLATED, HOWEVER, THE BALLOON WITHDRAWAL DIFFICULTY OCCURRED. THE BALLOON WAS STUCK IN THE STENT. SEVERAL BALLOON INFLATIONS AND DEFLATIONS WERE PERFORMED AND NITROGLYCERIN WAS DELIVERED INTO THE VESSEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE BALLOON. SEVERAL MORE BALLOON INFLATIONS AND DEFLATIONS WERE MADE. THE PHYSICIAN PUSHED AND PULLED. THEN WENT TO 16 ATM FOR 28 SECONDS AND BROUGHT IT DOWN AGAIN. FINALLY PULLED AND THE GUIDE DOVE DOWN MID WAY THROUGH THE STENT AND THEY WERE ABLE TO REMOVE THE BALLOON. THE BALLOON REMOVAL PROCESS TOOK 20 MINUTES. THEN A CLOT AND NO FLOW WERE DISCOVERED. AN ASPIRATION CATHETER WAS USED AND MORPHINE WAS GIVEN. A DISSECTION OCCURRED DISTAL TO THE STENT AND A 2.0X9 MM MAVERICK BALLOON WAS USED. A 2.50X8MM TAXUS EXPRESS2 WAS PLACED TO TREAT THE DISSECTION. PATIENT STATUS REPORTED AS "FINE/STABLE".

    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 2.75X28 MM 11319315

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention