BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1464432 · Received September 4, 2009

    Report

    Report Number
    2134265-2009-04532
    Event Type
    Injury
    Date Received
    September 4, 2009
    Date of Event
    March 26, 2008
    Report Date
    August 6, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. LITERATURE CITATION: VERY LATE THROMBOSIS OF A DRUG-ELUTING STENT AFTER DISCONTINUATION OF A DUAL ANTIPLATELET THERAPY IN PT TREATED WITH BOTH DRUG-ELUTING AND BARE-METAL STENTS. FOREIGN COUNTRY CIRC J 2009; 39: 205-208. KIM SS, JEONG MH, SIM DS, HONG, YJ, KIM JH, AHN YK & KANG, JC.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE, "VERY LATE THROMBOSIS OF A DRUG-ELUTING STENT AFTER DISCONTINUATION OF A DUAL ANTIPLATELET THERAPY IN PT TREATED WITH BOTH DRUG-ELUTING AND BARE-METAL STENTS," THAT POST PERCUTANEOUS CORONARY INTERVENTIONS (PCI), THROMBOSIS OCCURRED. THE PT PRESENTED WITH MYOCARDIAL INFARCTION (MI) AND ELECTIVE PCI WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA); A 2.75X32MM TAXUS LIBERTE STENT WAS IMPLANTED. POST STENTING PROCEDURE, THE PT WAS ADMINISTERED DUAL ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL). APPROX TWO YEARS LATER, THE PT RAN OUT OF HIS MEDICATION AND FAILED TO REFILL THE PRESCRIPTION; SIXTEEN DAYS LATER, HE PRESENTED WITH CHEST PAIN. AN ELECTROCARDIOGRAM SHOWED ST-SEGMENT DEPRESSION AND T-WAVE INVERSION IN LEAD II, III AND VF. CORONARY ANGIOGRAPHY REVEALED A TOTAL OCCLUSION OF THE TAXUS STENT DUE TO THROMBUS FORMATION AND GRADE II COLLATERAL FLOW. THE PT UNDERWENT BALLOON ANGIOPLASTY AND THROMBUS ASPIRATION. BLOOD FLOW WAS RESTORED WITHOUT RESIDUAL STENOSIS. NO ADDITIONAL PT COMPLICATIONS WERE REPORTED. AFTER THE PROCEDURE, THE PT WAS PLACED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.75X32MM 8377135

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention