BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3111412 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03578
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: MENG-HSIU CHIANG, WEN-LIENG LEE, CHENG-RONG TSAO, WEI-CHUN CHANG, CHIEH-SHOU SU, TSUN-JUI LIU, KAE-WOEI LIANG, CHIH-TAI TING; THE USE AND CLINICAL OUTCOMES OF ROTABLATION IN CHALLENGING CASES IN THE DRUG-ELUTING STENT ERA; JOURNAL OF THE CHINESE MEDICAL ASSOCIATION 76; JULY 2012; P.71-77. EVENT DATE: (B)(6) 2012. DEVICE IS 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

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT 67 PATIENTS WITH 71 SEVERELY CALCIFIED DE NOVO CORONARY LESIONS WERE SUCCESSFULLY TREATED WITH ROTATIONAL ATHERECTOMY (RA) FOLLOWED BY BALLOON DILATION AND PLACEMENT OF A DRUG ELUTING STENT. THE ANGIOGRAPHIC SUCCESS RATE WAS 100%. DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND CLOPIDOGREL WAS CONTINUED FOR AT LEAST 12 MONTHS POST IMPLANT. THE IMPLANTED STENTS INCLUDED A TAXUS STENT IN 24 LESIONS, A PROMUS STENT IN 9 LESIONS AND NON BSC STENTS IN THE REMAINING LESIONS. IT WAS NOTED THAT DURING THE PROCEDURES, 1 NON-Q MYOCARDIAL INFARCTION, 3 NHLBI TYPE B AND 2 TYPE C CORONARY DISSECTIONS OCCURRED. THE DISSECTIONS WERE TREATED SUCCESSFULLY BY STENTING AND NOT FOLLOWED BY MAJOR ADVERSE CARDIAC EVENTS (MACE). IT WAS ALSO NOTED THAT POST PROCEDURE 12 OUT-OF-HOSPITAL MACE OCCURRED. OF 18 CLINICALLY DRIVEN, ANGIOGRAPHIC FOLLOW-UP PATIENTS, 7 REQUIRED TARGET LESION REVASCULARIZATION DUE TO ISCHEMIA AND 7 REQUIRED TARGET VESSEL REVASCULARIZATIONS. ALL WERE SUCCESSFULLY REOPENED BY PERCUTANEOUS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212072 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention