BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 7094742 · Received December 7, 2017

    Report

    Report Number
    9612164-2017-01817
    Event Type
    Death
    Date Received
    December 7, 2017
    Date of Event
    September 5, 2017
    Report Date
    April 19, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557079
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CEC ADJUDICATED NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HIST REINFARCTION POST PCI AS AN EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC RE ADJUDICATED MI IN THE RCA AND CX AS NO EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED WITH MEDICATION TO TREAT HEART FAILURE. THE CAUSE OF DEATH IS LISTED AS CHF, PULMONARY EDEMA, ATRIAL FIB AND CAD. CEC ADJUDICATED THE DEATH EVENT AS CARDIAC DEATH. CEC ALSO ADJUDICATED STENT THROMBOSIS AS NO EVENT AND NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HISTORICAL REINFARCTION POST PCI AS NO EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED. ONE IN THE DISTAL CX AND ONE IN THE MID RCA. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED FROM HEART FAILURE AND PASSED AWAY. THE DEATH WAS A NON SUDDEN CARDIAC DEATH. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877728 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008440530 00643169557079

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death