BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 7099774 · Received December 8, 2017

    Report

    Report Number
    9612164-2017-01847
    Event Type
    Death
    Date Received
    December 8, 2017
    Date of Event
    January 1, 2017
    Report Date
    December 8, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLATELET DISTRIBUTION WIDTH AS THE PROGNOSTIC MARKER IN CORONARY BIFURCATION TREATMENT. DOI: 10.1111/ECI.12773. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TWO HUNDRED SIXTY NINE PATIENTS WERE INCLUDED IN THIS TWO-CENTRE OBSERVATION STUDY. OF THE 269 PATIENTS INCLUDED IN THE STUDY, 29 PATIENTS RECEIVED A RESOLUTE ONYX STENT. PROXIMAL MAIN VESSEL - DISTAL MAIN VESSEL ACROSS THE SIDE BRANCH, WAS THE DEFAULT STRATEGY IN ALL PATIENTS. DURING 12-MONTHS FOLLOW-UP MACE INCIDENTS (DEATH AND MYOCARDIAL INFARCTION) AND TARGET LESION REVASCULARIZATION WERE REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878097 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death