BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8627542 · Received May 21, 2019

    Report

    Report Number
    9612164-2019-01859
    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 NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI PERI-PCI - PROX LAD. CEC ADJUDICATED THE EVENT DATE AS (B)(6) 2018. 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
    421141 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008914211

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization