BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2925564 · Received January 22, 2013

    Report

    Report Number
    2134265-2013-00148
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 RELEVANT 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: 2134265-2013-00147. IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED STENT THROMBOSIS AND A MYOCARDIAL INFARCTION. IN (B)(6) 2009 THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE REVEALING ONE TARGET LESION. A 3.50X32MM AND 3.50X16MM TAXUS STENTS WERE IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). JUST OVER THREE YEARS LATER THE PATIENT RETURNED AND A ST-ELEVATED MYOCARDIAL INFARCTION WAS DIAGNOSED (PEAK CK TOTAL= 485, ULN=269 IU/L; CK-MB=61.2, ULN= 5.0 NG/ML; PEAK TROPONIN= 15.65, ULN= 0.20 NG/ML). CORONARY ANGIOGRAPHY REVEALED A THROMBUS AND 100% OCCLUSION OF THE PROXIMAL RCA STENTS THAT WERE DEPLOYED IN (B)(6) 2009. A 3.50X40MM APEX MONORAIL BALLOON CATHETER WAS ADVANCED AND ANGIOPLASTY WAS PERFORMED RESULTING IN 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED TWO DAYS LATER WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29438 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616350 12558918

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention