BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 10866618 · Received November 19, 2020

    Report

    Report Number
    9612164-2020-04478
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    June 28, 2020
    Report Date
    November 19, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169556850
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 DES WERE IMPLANTED IN THE LAD. ONE RESOLUTE ONYX DES WAS IMPLANTED DURING ANOTHER REVASC TO TREAT THE 1ST OBTUSE MARGINAL. APPROXIMATELY 34 MONTHS LATER, THE PATIENT SUFFERED MI. EVENT WAS TREATED WITH HOSPITALIZATION, MEDICATION AND PCI. PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE ANTI-PLATELET MEDICATION. SAFETY COMMENTED "REVASC NTV". STENTING WAS CARRIED OUT IN THE 1ST OBTUSE MARGINAL AND RCA DURING A REVASCULARIZATION PROCEDURE. CEC ADJUDICATED MI AS NON-Q-WAVE MI OF THE RCA AND THE CX (NON-TARGET VESSEL). CEC ADJUDICATED REVASCULARIZATION OF THE RCA AND CX AS NON-TVR-PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332149 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND RONYX25034UX 0009829299 00643169556850

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| R