BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3965158 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04640
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 STENT DAMAGE AND STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 20MM LONG, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE 24MM X 4.00MM TAXUS¿ LIBERTÉ¿ STENT WAS ADVANCED FOR DIRECT STENTING BUT WAS UNABLE TO CROSS THE LESION. DURING AN ATTEMPT TO RETRACT THE DEVICE INTO AN UNSPECIFIED GUIDE CATHETER, THE STENT WAS DEFORMED. THE WHOLE SYSTEM WAS REMOVED TOGETHER, HOWEVER THE STENT WAS DISLODGED IN THE FEMORAL ARTERY. THE PHYSICIAN WAS FORCED TO DEPLOY THE STENT IN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE NOTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441480 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894024400 16547354

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other