BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8381454 · Received March 1, 2019

    Report

    Report Number
    9612164-2019-00739
    Event Type
    Death
    Date Received
    March 1, 2019
    Date of Event
    August 3, 2018
    Report Date
    November 16, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED THE DEATH AS CARDIAC DEATH AND COMMENTED THE PATIENT DIED FROM COMPLICATIONS FROM A MASSIVE MI. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CEC RE-ADJUDICATED THE DEATH EVENT OCCURRED ON (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CEC ADJUDICATED THE DEATH EVENT OCCURRED ON THE (B)(6) 2018. 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 DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 2 WEEKS POST INDEX PROCEDURE, IT IS REPORTED THAT PATIENT DIED, THE CAUSE OF DEATH IS UNKNOWN. THE SITE ASSESSED THAT THE DEATH WAS NOT RELATED TO THE DEVICE OR ANTIPLATELETS. THE SPONSOR ASSESSED THAT THE DEVICE WAS POSSIBLY RELATED TO THE DEVICE AND ANTIPLATELETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174785 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009029950

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death