BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 6844244 · Received September 6, 2017

    Report

    Report Number
    9612164-2017-01224
    Event Type
    Death
    Date Received
    September 6, 2017
    Date of Event
    July 26, 2017
    Report Date
    March 15, 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

    CEC ADJUDICATED NON-Q-WAVE MI (VESSEL UNKNOWN), MDT EXTENDED HISTORICAL SPONTANEOUS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CEC ADJUDICATED THE DEATH AS A CARDIAC DEATH. CEC ALSO ADJUDICATED STENT THROMBOSIS AS NOT AN EVENT. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN APPROXIMATELY ONE MONTH POST INDEX PROCEDURE. THE PATIENT WAS FOUND TO BE HYPOTENSIVE WITH A CHANGE IN MENTAL STATUS AND UNILATERAL WEAKNESS OF RUE AND RLE. THE PATIENT REQUIRED BOLUS FOR HYPOTENSION. APPROXIMATELY SEVEN WEEKS POST INDEX PROCEDURE, THE PATIENT WAS NON-RESPONSIVE TO STIMULI AND WAS TRANSFERRED TO ICU, AND THE PATIENT DIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS YEAR VALID ONLY.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED IN THE PROX LAD. APPROXIMATELY ONE MONTH POST PROCEDURE THE PATIENT SUFFERED EXTENSIVE CORONARY ARTERY DISEASE. THE PATIENT WAS TREATED WITH MEDICATION BUT RESPIRATORY STATUS DECLINED. COMFORT MEASURES WERE TAKEN BUT THE PATIENT DIED. DEATH WAS NON SUDDEN CARDIAC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625134 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008438948

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death