BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8369705 · Received February 26, 2019

    Report

    Report Number
    9612164-2019-00644
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    August 22, 2017
    Report Date
    April 19, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A SMOKER. THE SITE NOTED THE EVENT DATE AS (B)(6) 2017. THE RCA WAS THE LOCATION THAT INDICATED MI. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC RE ADJUDICATED MI IN THE RCA AS NO EVENT. THE EVENT DATE HAS BEEN UPDATED. 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.

    Additional Manufacturer Narrative · 1

    CEC READJUDICATED MI AS NO EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATED MI AS A NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HISTORICAL REINFARCTION POST PCI. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT IMPLANTED IN THE RCA. IT WAS REPORTED THAT THE PATIENTS TROPONIN LEVELS WERE ELEVATED POST PROCEDURE. CEC ADJUDICATED MI AS A NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HISTORICAL PERI-PCI. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165854 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008623028

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization