BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8059467 · Received November 12, 2018

    Report

    Report Number
    9612164-2018-03148
    Event Type
    Death
    Date Received
    November 12, 2018
    Date of Event
    September 22, 2018
    Report Date
    November 12, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIN COMPOSITE WIRE STRUT, DURABLE POLYMER-COATED (RESOLUTE ONYX) VERSUS ULTRATHIN COBALT¿CHROMIUM STRUT, BIORESORBABLE POLYMER-COATED (ORSIRO) DRUG-ELUTING STENTS IN ALLCOMERS WITH CORONARY ARTERY DISEASE (BIONYX): AN INTERNATIONAL, SINGLE-BLIND, RANDOMISED NON-INFERIORITY TRIAL. DOI.ORG/10.1016/ S0140-6736(18)32001-4. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BETWEEN OCT 7, 2015, AND DEC 23, 2016, 2516 PATIENTS WERE ENROLLED. 1243 PARTICIPANTS WERE ASSIGNED TO THE RESOLUTE ONYX GROUP. COLLECTIVELY, PATIENTS PRESENTED WITH ACS, ACUTE MI, STEMI, NON-STEMI, UNSTABLE ANGINA, STABLE ANGINA. COLLECTIVE LESION CHARACTERISTICS INCLUDED AT LEAST ONE COMPLEX LESION, AT LEAST ONE BIFURCATION LESION, AT LEAST ONE CHRONIC TOTAL OCCLUSION, AT LEAST ONE BYPASS GRAFT LESION, AT LEAST ONE SEVERELY CALCIFIED LESION. LESION LOCATION COLLECTIVELY INCLUDED LEFT MAIN, LAD, LCX, RCA, BYPASS GRAFT AND EXHIBITING SEVERE CALCIFICATION, BIFURCATION, IN-STENT RESTENOSIS, CHRONIC TOTAL OCCLUSION. ADVERSE EVENTS POST PROCEDURE INCLUDED DEATH INCLUDING CARDIAC DEATH, MI, TARGET VESSEL REVASCULARISATION, TARGET LESION REVASCULARISATION AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900092 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death