BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8603008 · Received May 13, 2019

    Report

    Report Number
    9612164-2019-01699
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    September 27, 2018
    Report Date
    May 13, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE LAD. IT WAS REPORTED THAT THE CEC ADJUDICATED MI AS A NON Q WAVE MI, 3RD UDMI PERI PCI IN THE LAD. THE CEC COMMENTED THAT FROM FILM REVIEW, NO SIDE BRANCH OCCLUSION WAS OBSERVED BUT NEW ST- T WAVES IN THE ANTERIOR LEADS WERE PRESENT. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396479 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009200689

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR