BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2042503 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01132
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 2.25X28MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) IT WAS NOTED THAT THE STENT WAS DAMAGED. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

    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 H7493893628220 13548137

    Patients

    Seq Age Sex Outcome Treatment
    1