BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8627487 · Received May 21, 2019

    Report

    Report Number
    9612164-2019-01858
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    July 11, 2018
    Report Date
    May 21, 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.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE LAD. CEC ADJUDICATED THE EVENT DATE AS (B)(6) 2018. CEC ADJUDICATED NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI PERI-PCI - PROX LAD. CEC COMMENTED THAT SIDE BRANCH OCCLUSION IN THE LAD WAS OBSERVED. ENZYMES WERE INCREASING PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420243 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008890993

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization