BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8695091 · Received June 13, 2019

    Report

    Report Number
    9612164-2019-02317
    Event Type
    Death
    Date Received
    June 13, 2019
    Date of Event
    March 15, 2019
    Report Date
    August 20, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED DEATH EVENT AS CARDIAC DEATH. MI EVENT AS NO EVENT BECAUSE THERE WAS NO RECORD OF ENZYMES TO DOCUMENT MI. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AE TERM CHANGE TO MYOCARDIAL INFARCTION. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH, ACUTE MI, IT IS UNKNOWN OF THE TARGET VESSEL WAS INVOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTIPLATELET MEDICATION. THE STENT WAS IMPLANTED IN THE 2ND RPL AND NOT THE 3RD LPL AS WAS PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED IN THE 3RD LPL. APPROX. 10 MONTHS POST INDEX PROCEDURE, THE PATIENT DIED. IT WAS ASSUMED THAT THE DEATH WAS CARDIAC RELATED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTIPLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488958 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009054165

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death