BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8150451 · Received December 11, 2018

    Report

    Report Number
    9612164-2018-03550
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    December 13, 2017
    Report Date
    March 14, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169556829
    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.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATION; CEC ADJUDICATED STENT THROMBOSIS AS NOT AN EVENT. CEC ADJUDICATED NON Q WAVE MI (TV) AS A NON EVENT. PATIENT HAS A MEDICAL HISTORY OF HYPERLIPIDEMIA, CHRONIC RENAL INSUFFICIENCY, MULTI-VESSEL CORONARY ARTERY DISEASE, AND PREVIOUS PCI. DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE 1ST DIAGONAL AND THREE IMPLANTED IN THE LAD. ORBITAL ATHERECTOMY OF LAD WAS ALSO PERFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATION STILL NON-Q-WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI-PCI IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; FOUR IN THE LAD AND ONE IN THE 1ST DIAGONAL AND TWO NC EUPHORA BALLOONS WERE USED IN THE LAD. ON THE SAME DAY , PATIENT SUFFERED ELEVATED TROPONIN AND RECOVERED THE FOLLOWING DAY. CEC A DJUDICATED THE EVENT AS NON-Q WAVE MYOCARDIAL INFARCTION OF THE TARGET VESSEL. INVESTIGATOR ASSESSED THE EVENT IS UNLIKELY RELATED TO DEVICE AND NOT RELATED TO ANTIPLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992188 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008824232 00643169556829

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization