BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8381187 · Received March 1, 2019

    Report

    Report Number
    9612164-2019-00733
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    August 8, 2017
    Report Date
    April 19, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169557086
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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

    CEC RE-ADJUDICATED MI AS NO EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT IS A PREVIOUS SMOKER WITH A MEDICAL HISTORY OF MI AND PCI. THE INDEX PROCEDURE WAS PROMPTED BY MI. DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX STENTS WERE IMPLANTED; TWO IN THE LAD AND ONE INTO THE 1ST DIAGONAL. ONE DAY POST INDEX PROCEDURE IT WAS REPORTED THAT THE PATIENTS CARDIAC ENZYMES WERE ELEVATED. CEC ASSESSED THE MI EVENT AS NON Q WAVE MI (TARGET VESSEL), MDT EXTENDED, HISTORICAL PERI-PCI. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT. CEC ADJUDICATED THE EVENT DATE AS SAME DATE AS INDEX PROCEDURE. THE LAD AND 1ST DIAGONAL INDICATED MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175904 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008618053 00643169557086

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization