BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2161776 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02960
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 6F GUIDE CATHETER WAS ADVANCED, PREDILATION WAS PERFORMED, AND A 2.75X28MM TAXUS LIBERTE STENT WAS PLACED. DURING REMOVAL OF THE STENT DELIVERY BALLOON "SEVERE" BALLOON WITHDRAWAL RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY BALLOON BY INFLATING AND DEFLATING THE BALLOON, PUSHING FORWARD AND PULLING BACK SEVERAL TIMES WITH DEEP SEATING OF THE GUIDE CATHETER. THE BALLOON WAS SUCCESSFULLY REMOVED AFTER APPROXIMATELY (B)(6). THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628270

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC 6F EBU GUIDE CATHETER