BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2936182 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00223
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 4, 2013
    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

    (B)(6). DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MFR: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID#: 2134265-2013-00224. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD RESTENOSIS IN THE STENTED VESSEL. IN AUG 2009, THE PATIENT HAD MYOCARDIAL INFARCTION. TWO TAXUS LIBERTE STENTS OF SIZE 3.5X32MM AND 3.5X16 MM WERE PLACED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). IN DEC 2012, THE SITE REPORTED AN EVENT OF CORONARY ARTERY DISEASE AND THE PATIENT WAS HOSPITALIZED. CORONARY ANGIOGRAPHY REVEALED 70% STENOSIS IN THE MID RCA, WHICH WAS TREATED WITH PLACEMENT OF A 2.75X20MM PROMUS ELEMENT PLUS STENT WITH 0% RESIDUAL STENOSIS. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41590 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632350 12469778

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R