BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1221535 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04229
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025/S21
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-04228. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN PLACED A TAXUS ATOM DRUG ELUTING STENT IN THE LAD AND WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DELIVERY DEVICE, WITHDRAWAL RESISTANCE WAS ENCOUNTERED. WHILE ATTEMPTING TO RETRIEVE THE DEVICE, THE GUIDE WAS PULLED INTO THE DIAGONAL ARTERY AND GUIDE WIRE POSITION WAS LOST. THE PHYSICIAN REPOSITIONED THE GUIDE WIRE AND INFLATED THE BALLOON TO A HIGHER PRESSURE AND THE BALLOON CAME DOWN. A SECOND TAXUS ATOM DRUG ELUTING STENT WAS THEN DEPLOYED AND THE PHYSICIAN ENCOUNTERED THE SAME DIFFICULTY. THIS BALLOON CAME FREE AFTER REINFLATING THE BALLOON, WITH AN INDEFLATOR, TO A HIGHER PRESSURE AND THEN DIALING DOWN SLOWLY. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1