BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8522179 · Received April 17, 2019

    Report

    Report Number
    9612164-2019-01375
    Event Type
    Death
    Date Received
    April 17, 2019
    Date of Event
    March 18, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THAT DEATH EVENT IS ASSOCIATED TO STENT THROMBOSIS. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE BUT CAUSALLY RELATED TO THE ANTIPLATELET MEDICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AE TERM CHANGE TO SUB ACUTE THROMBOSIS OF STENT. CAUSE OF DEATH IS CARDIAC ARREST AND WITH UNDERLYING CAUSE OF ACUTE MI AND CAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED DEATH AS CARDIAC DEATH OF UNKNOWN CAUSE, SUSPECTED STENT THROMBOSIS. CEC ALSO ADJUDICATED THE MI AS NO EVENT. CEC ADJUDICATED THE STENT THROMBOSIS AS SUBACUTE ST ARC PROBABLE. 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 STENT WAS IMPLANTED INTO THE LAD. APPROX 1 MONTH POST INDEX PROCEDURE THE PATIENT DIED. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314989 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008894096

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death