BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8435383 · Received March 20, 2019

    Report

    Report Number
    9612164-2019-00940
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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, TWO EUPHORA PTCA BALLOON CATHETERS WERE USED TO PRE-DILATE THE R-PDA AND R-PAV. ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE R-PDA AND A PLAQUE SHIFT OCCURRED INTO THE R-PAV. THE EVENT WAS TREATED WITH POST DILATION USING FOUR NC EUPHORA PTCA BALLOON CATHETERS. THE INVESTIGATOR ASSESSED THE EVENT WAS CAUSALLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTI PLATELET MEDICATION. IT WAS REPORTED THAT THE PRE-DILATION EUPHORA BALLOONS WERE NOT INVOLVED IN THE PLAQUE SHIFT. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230586 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009092378

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention