BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932039 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05532
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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 PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. WHILE PREPPING THE TAXUS LIBERTE, ATOM (MR) 20 X 2.25MM STENT IT WAS NOTED THAT THE STRUTS WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620220 12939669

    Patients

    Seq Age Sex Outcome Treatment
    1