BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8665820 · Received June 4, 2019

    Report

    Report Number
    9612164-2019-02141
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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- ONE INTO THE R-PDA AND ONE INTO THE RCA. APPROX 10 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A CVA - STROKE. THE PATIENT HAS NOT RECOVERED. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462441 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009100572

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization