BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 2982141 · Received February 28, 2013

    Report

    Report Number
    9612164-2013-00220
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    October 5, 2010
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (DEATH, MI, STENT THROMBOSIS AND RESTENOSIS OF THE STENTED VESSEL). (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4). LITERATURE REFERENCE: COMPARISON OF ZOTAROLIMUS-ELUTING STENTS WITH SIROLIMUS- AND PACLITAXEL-ELUTING STENTS FOR CORONARY REVASCULARIZATION-JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, JACC VOL. 56, NO. 15, 2010 OCTOBER 5, 2010:1187-95. AGE AT TIME OF EVENT - BASELINE AGE, DATE OF EVENT - DATE OF PUBLICATION OF ARTICLE.

    Description of Event or Problem · 1

    THE AIM OF THIS STUDY WAS TO EVALUATE THE RELATIVE EFFICACY AND SAFETY OF ZOTAROLIMUS-ELUTING STENTS (ZES) (ENDEAVOR) IN COMPARISON WITH THE ESTABLISHED AND WIDELY USED SIROLIMUS- (SES) AND PACLITAXEL-ELUTING STENTS (PES) IN ROUTINE CLINICAL PRACTICE. WHETHER ZES MIGHT PROVIDE SIMILAR CLINICAL AND ANGIOGRAPHIC OUTCOMES IN A BROAD SPECTRUM OF PATIENTS COMPARED WITH SES OR PES IS UNDETERMINED. A SINGLE-BLIND, MULTICENTER, PROSPECTIVELY RANDOMIZED TRIAL WAS PERFORMED TO COMPARE ZES WITH SES AND PES IN 2,645 PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE PRIMARY END POINT WAS A COMPOSITE OF MAJOR ADVERSE CARDIAC EVENTS (MACE) (DEATH, MYOCARDIAL INFARCTION, AND ISCHEMIA-DRIVEN TARGET VESSEL REVASCULARIZATION) AT 12 MONTHS. A NONINFERIORITY COMPARISON (ZES VS. SES) AND A SUPERIORITY COMPARISON (ZES VS. PES) WERE PERFORMED FOR THE PRIMARY END POINT. BASELINE CLINICAL AND ANGIOGRAPHIC CHARACTERISTICS WERE SIMILAR IN THE 3 GROUPS. AT 12 MONTHS, THE ZES GROUP SHOWED NON-INFERIOR RATES OF MACE COMPARED WITH THE SES GROUP (10.2% VS. 8.3%, P FOR NON-INFERIORITY _ 0.01, P FOR SUPERIORITY _ 0.17) AND SIGNIFICANTLY FEWER MACE THAN THE PES GROUP (10.2% VS. 14.1%, P FOR SUPERIORITY _ 0.01). THE INCIDENCE OF DEATH OR MYOCARDIAL INFARCTION WAS SIMILAR AMONG THE GROUPS (ZES VS. SES VS. PES, 5.8% VS. 6.9% VS. 7.6%, RESPECTIVELY, P _ 0.31). THE INCIDENCE OF STENT THROMBOSIS WAS SIGNIFICANTLY LOWER IN THE SES GROUP (ZES VS. SES VS. PES, 0.7% VS. 0% VS. 0.8%, RESPECTIVELY, P _ 0.02). TO CONCLUDE, IN THIS LARGE-SCALE PRACTICAL RANDOMIZED TRIAL, THE USE OF ZES RESULTED IN SIMILAR RATES OF MACE COMPARED WITH SES AND IN FEWER MACE COMPARED WITH PES AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86775 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR ASPIRIN AND CLOPIDOGREL