BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2071888 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01508
    Event Type
    Injury
    Date Received
    April 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT DATE: (B)(6) 2010. IF IMPLANTED, GIVE DATE: (B)(6) 2010. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE 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, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010, A TAXUS LIBERTE ATOM STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER IMPLANTATION OF THE STENT THE PATIENT EXPERIENCED AN ALLERGIC REACTION WITH SYMPTOMS OF A RASH, SHORTNESS OF BREATH AND DECREASED BLOOD PRESSURE. THE PATIENT WAS HOSPITALIZED FOR 2-3 DAYS. TWO MONTHS LATER THE PATIENT BEGAN TO EXPERIENCE UNSTABLE ANGINA AND IN-STENT RESTENOSIS WAS DISCOVERED IN THE PREVIOUSLY IMPLANTED TAXUS LIBERTE ATOM STENT. A 2.25MM UNSPECIFIED BARE METAL STENT WAS SUCCESSFULLY IMPLANTED IN THE LESION FOR TREATMENT OF THE IN-STENT RESTENOSIS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS EXCELLENT.

    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 Required Intervention