BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1833648 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04146
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE OCCURRED. A COMMENT WAS MADE BY THE PHYSICIAN THAT AFTER DEPLOYING A TAXUS LIBERTE STENT, HE EXPERIENCED DIFFICULTY WHEN WITHDRAWING THE STENT DELIVERY BALLOON FROM THE DEPLOYED STENT. IT WAS NOTED THAT THE BALLOON WAS FULLY DEFLATED BEFORE ATTEMPTING TO REMOVE IT FROM THE PATIENT AND THE STENT WAS FULLY EXPANDED AND SUCCESSFULLY DEPLOYED. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT DELIVERY BALLOON FROM THE PATIENT "NORMALLY" WITHOUT ADDITIONAL INTERVENTION. IT WAS NOTED THAT THE STENT STAYED WELL POSITIONED AND APPOSED IN THE LESION AFTER THE REMOVAL OF THE STENT DELIVERY BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1