BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2041164 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01287
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 11, 2011
    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

    DEVICE EVALUATED BY MANUFACTURER:THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED BATCH CONFIRMED THAT THE DEVICES MET ALL APPLICABLE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED.THE LESION BEING TREATED WAS LOCATED IN A VERY TIGHT LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.25X24MM TAXUS ATOM STENT IN THE TARGET LESION. THE STENT BUCKLED IN THE CENTER BUT WAS STILL ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT CONDITION IS STATED AS 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 H7493893624220 13444346

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR