BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 7218173 · Received January 25, 2018

    Report

    Report Number
    9612164-2018-00148
    Event Type
    Death
    Date Received
    January 25, 2018
    Date of Event
    October 25, 2017
    Report Date
    December 14, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557079
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 ADJUDICATED THE DEATH EVENT AS A CARDIAC DEATH. CEC ALSO ADJUDICATED THE STENT THROMBOSIS AS NO EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE A RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED SUCCESSFULLY IN THE LAD. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. CAUSE OF DEATH IS UNKNOWN. INVESTIGATOR ASSESSMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63081 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND RONYX35015UX 0008440526 00643169557079

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death