BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 7439208 · Received April 18, 2018

    Report

    Report Number
    9612164-2018-00825
    Event Type
    Death
    Date Received
    April 18, 2018
    Date of Event
    August 25, 2017
    Report Date
    April 18, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: A MULTICENTER REGISTRY EVALUATING PERCUTANEOUS CORONARY INTERVENTION WITH NEW-GENERATION DRUG-ELUTING STENTS IN PATIENTS WITH OBSTRUCTIVE LEFT MAIN CORONARY ARTERY DISEASE. AUTHORS: ALAIDE CHIEFFO, MD, AKIHITO TANAKA, MD, GENNARO GIUSTINO, MD, ET AL. LITERATURE REFERENCE: D X. D O I. O R G / 1 0. 1 0 1 6 / J. J C I N. 2 0 1 7. 0 8. 0 50 JOURNAL: J A C C : C A R D I OV A S C U L A R I N T E R V E N T IO N S ISSUE #: 2 3 YEAR: 2 0 1 7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING PROCEDURES, ENDEAVOR, RESOLUTE INTEGRITY AND RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD/LCX AND RCA. THE FOLLOWING IN-HOSPITAL AND CLINICAL FOLLOW-UP OUTCOMES WERE REPORTED - DEATH, MYOCARDIAL INFARCTION, TLR, TVR, STENT THROMBOSIS AND CEREBROVASCULAR EVENT. SOME OF THE REPORTED DEATH EVENTS WERE ADJUDICATED CARDIAC DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281835 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death