BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8324839 · Received February 11, 2019

    Report

    Report Number
    9612164-2019-00466
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    December 1, 2018
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED MI AS A NON Q WAVE MI (TARGET VESSEL) 3RD UDMI SPONTANEOUS IN THE LAD. CEC ADJUDICATED THE MI EVENT DATE AS (B)(6) 2019. CEC ADJUDICATED THE REVASCULARISATION AS A TLR PERCUTANEOUS INTERVENTION THAT WAS CLINICALLY DRIVEN. CEC COMMENTED THAT FILM WAS REVIEWED SHOWING EDGE STENOSIS. THE CEC ADJUDICATED THE REVASCULARISATION EVENT DATE AS THE (B)(4) 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. APPROX 4 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED NSTEMI. THE PATIENT WAS TREATED WITH IMPLANTATION OF A RESOLUTE ONYX STENT IN THE LAD. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO ANTI-PLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122757 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008818034

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R