BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 8027829 · Received November 1, 2018

    Report

    Report Number
    9612164-2018-03020
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    June 11, 2018
    Report Date
    November 1, 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

    TITLE: EXTENDED CLOPIDOGREL THERAPY BEYOND 12 MONTHS AND LONG-TERM OUTCOMES IN PATIENTS WITH DIABETES MELLITUS RECEIVING CORONARY ARTERIAL SECOND-GENERATION DRUG-ELUTING STENTS. AUTHORS: CHO, SUNG WOO;PARK, KYUTAE; AHN, JONG-HWA; PARK, TAEK KYU; LEE, SU YEON; KIM, JIHOON; LEE, JOO MYUNG; YANG, JEONG HOON; SONG, YOUNG BIN; CHOI, JIN-HO; CHOI, SEUNG-HYU ; GWON, HYEON-CHEOL; LEE, SANG HOON; AHN, JOONGHYUN; CARRIERE, K.C.; HAHN, JOO-YONG; HAHN, JOO-YONG JOURNAL: THE AMERICAN JOURNAL OF CARDIOLOGY ISSUE: VOLUME 122, ISSUE 5, PAGES 705¿711 REF: DOI.ORG/10.1016/J.AMJCARD.2018.05.001. DATE OF ONLINE PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL WAS SUBMITTED WHICH INVESTIGATED THE ASSOCIATIONS BETWEEN EXTENDED CLOPIDOGREL THERAPY AND LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH DIABETES MELLITUS(DM) AFTER SECOND-GENERATION DRUG-ELUTING STENT(DES)IMPLANTATION. ENDEAVOR, ENDEAVOR SPRINT AND ENDEAVOR RESOLUTE DES WERE IMPLANTED IN A PERCENTAGE OF THE POPULATION. CLINICAL EVENTS REPORTED IN PATIENTS DURING FOLLOW UP INCLUDED DEATH, MI, BLEEDING AND CEREBROVASCULAR ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867537 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention