BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8098491 · Received November 22, 2018

    Report

    Report Number
    9612164-2018-03314
    Event Type
    Death
    Date Received
    November 22, 2018
    Date of Event
    September 28, 2018
    Report Date
    February 25, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ASSESSED THE DEATH AS CARDIAC DEATH. CEC ASSESSED THE STROKE AS EMBOLIC STROKE DUE TO ATRIAL FIBRILATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED DEATH, VASCULAR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST LPL. APPROXIMATELY 15 DAYS POST INDEX PROCEDURE EMBOLIC STROKE WAS REPORTED. THE PATIENT WAS HOSPITALIZED BUT DIED. THE DEATH WAS NON-CARDIAC. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, BUT POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE BUT NOT RELATED TO THE ANTI-PLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938525 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009122732

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H