BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 7369102 · Received March 26, 2018

    Report

    Report Number
    9612164-2018-00556
    Event Type
    Death
    Date Received
    March 26, 2018
    Date of Event
    January 1, 2018
    Report Date
    March 26, 2018
    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

    LITERATURE ARTICLE TITLE: SHORT-TERM VERSUS LONG-TERM DUAL ANTIPLATELET THERAPY AFTER DRUG-ELUTING STENT IMPLANTATION IN ELDERLY PATIENTS A META-ANALYSIS OF INDIVIDUAL PARTICIPANT DATA FROM 6 RANDOMIZED TRIALS. AUTHORS: SEUNG-YUL LEE, MD, MYEONG-KI HONG, MD, PHD, TULLIO PALMERINI, MD, HYO-SOO KIM, MD, MARCO VALGIMIGLI, MD, FAUSTO FERES, MD, ANTONIO COLOMBO, MD, MARTINE GILARD, MD, DONG-HO SHIN, MD, JUNG-SUN KIM, MD, BYEONG-KEUK KIM, MD, YOUNG-GUK KO, MD, DONGHOON CHOI, MD, YANGSOO JANG, MD, GREGG W. STONE, MD JOURNAL NAME: J A C C : CARDIOVASCULAR INTERVENTIONS D O I . O R G / 1 0 . 1 0 1 6 / J . J C ENDEAVOR RX NOT APPROVED IN THE USA BUT IS SIMILAR TO ENDEAVOUR SPRINT RX. ENDEAVOUR SPRINT RX IS APPROVED FOR IN THE USA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY WAS TO EVALUATE THE OPTIMAL DURATION OF DUAL ANTIPLATELET THERAPY (DAPT) AFTER THE IMPLANTATION OF DRUG-ELUTING STENT (DES) IN ELDERLY PATIENTS. ENDEAVOR ZOTAROLIMUS-ELUTING STENTS WERE IMPLANTED IN THE LEFT MAIN, LEFT ANTERIOR DESCENDING ARTERY, LEFT CIRCUMFLEX ARTERY AND RIGHT CORONARY ARTERY. AT 6 MONTHS AND 12 MONTHS FOLLOW UP, THE FOLLOWING CLINICAL OUTCOMES WERE REPORTED - CARDIAC AND NON-CARDIAC DEATHS, MYOCARDIAL INFARCTION, DEFINITE OR PROBABLE STENT THROMBOSIS, STROKE AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214478 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death