BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1850384 · Received October 1, 2010

    Report

    Report Number
    2134265-2010-04333
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE A STROKE OCCURRED. A 2.25X12MM TAXUS LIBERTE ATOM STENT WAS SUCCESSFULLY IMPLANTED IN THE DIAGONAL ARTERY AND IT WAS NOTED THAT THE PATIENT'S CONDITION WAS STABLE AT THE COMPLETION OF THE PROCEDURE. FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED WHAT WAS THOUGHT TO BE A STROKE. THE PATIENT WAS SENT FOR AN MRI TO TRY TO DETERMINE WHETHER OR NOT A STROKE ACTUALLY OCCURRED. THE PHYSICIAN DOES NOT THINK THE IMPLANTED TAXUS LIBERTE ATOM STENT CAUSED THE STROKE; HOWEVER, THE CAUSE OF THE STROKE IS UNKNOWN.

    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 H7493893612220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention