BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8611010 · Received May 15, 2019

    Report

    Report Number
    9612164-2019-01728
    Event Type
    Death
    Date Received
    May 15, 2019
    Date of Event
    September 15, 2018
    Report Date
    September 20, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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

    LOT DETAILS RECEIVED FOR PLI 20 AND 30. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CEC COMMENTED THAT PATIENT ADMITTED WITH NSTEMI. NO CHANGE IN ADJUDICATION. 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 IN THE LAD AND ONE IMPLANTED IN THE 1ST DIAGONAL. TWO DAYS POST INDEX PROCEDURE, THE PATIENT DIED. CAUSE OF DEATH IS ACUTE CORONARY SYNDROME TRO ISR. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTIPLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTIPLATELET MEDICATION. CEC ASSESSED THAT THE MI WAS A NON EVENT. CEC ASSESSED THE DEATH AS CARDIAC DEATH. CEC ADJUDICATED ARC PROBABLE SUBACUTE STENT THROMBOSIS IN THE TARGET VESSEL LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406021 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008962445

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death| H