BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8281361 · Received January 28, 2019

    Report

    Report Number
    9612164-2019-00339
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    August 30, 2017
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE INDEX PROCEDURE WAS ALSO PROMPTED BY A POSITIVE FUNCTIONAL STUDY. CEC ADJUDICATED NON-Q-WAVE MI OF RCA <(>&<)> CX. 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 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE LXC AND RCA. CEC ADJUDICATED NON-Q-WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI-PCI AND ADJUDICATED STENT THROMBOSIS AS NO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75619 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008501126

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR