BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 11912464 · Received June 1, 2021

    Report

    Report Number
    9612164-2021-02138
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    February 8, 2019
    Report Date
    June 1, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557024
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 1ST LPL. ONE DAY AFTER THE PROCEDURE PATIENT SUFFERED FROM ELEVATED TROPONIN POST PROCEDURE. CEC ADJUDICATED A TARGET VESSEL MI OCCURRED (1ST LPL) AND COMMENTED "CARDIAC ENZYMES FALLING PRIOR TO PROCEDURE, THEN SIGNIFICANT RISE POST PROCEDURE". THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808863 RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND RONYX30030UX 0009354131 00643169557024

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR