BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3895145 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03748
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    SAME CASE AS MDR ID: 2134265-2014-03553, 2134265-2014-03552, 2134265-2014-03973, 2134265-2014-03554, 2134265-2014-03750 AND 2134265-2014-03749. IT WAS REPORTED THAT THE STENT COLLAPSED. IN 2007, FOUR TAXUS EXPRESS2 STENTS WERE IMPLANTED IN AN UNSPECIFIED LESION. IT WAS NOTED THAT THE FOUR STENTS ¿COLLAPSED¿ AND THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT RECEIVED AN ADDITIONAL TAXUS EXPRESS2 STENT, 2.75X12MM TAXUS LIBERTE STENT AND A 2.25X16MM TAXUS LIBERTE ATOM STENT TO OPEN THE PREVIOUSLY PLACED COLLAPSED STENTS. HOWEVER, IT WAS NOTED THAT THESE STENTS ALSO COLLAPSED IN THE YEARS FOLLOWING IMPLANTATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372137 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893612270

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other