BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 7600265 · Received June 14, 2018

    Report

    Report Number
    9612164-2018-01447
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 8, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL NAME: CARDIOLOGY JOURNAL YEAR: 2018 AUTHORS: YONGCHEOL KIM, SUNG SIK OH, MYUNG HO JEONG, YOUNGKEUN AHN, JU HAN KIM, YOUNG JOON HONG, DOO SUN SIM, MIN CHUL KIM, HYO-SOO KIM, KYEONG HO YUN, SEOK KYU OH, CHONG JIN KIM, MYEONG CHAN CHO TITLE OF ARTICLE: COMPARISON OF SHORT-TERM CLINICAL OUTCOMES BETWEEN RESOLUTE ONYX ZOTAROLIMUS-ELUTING STENTS AND EVEROLIMUS-ELUTING STENT IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION: RESULTS FROM THE KOREA ACUTE MYOCARDIAL INFARCTION REGISTRY (KAMIR). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE STUDY COMPARED THE CLINICAL OUTCOMES OF MEDTRONIC RESOLUTE ONYX ZOTAROLIMUS-ELUTING STENT (O-ZES) AND NON-MEDTRONIC EVEROLIMUS-ELUTING STENTS (EES) IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION UNDERGOING SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI). RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN 402 PATIENTS IN THE STUDY POPULATION. THE PRIMARY ENDPOINT WAS TARGET-LESION FAILURE DEFINED AS COMPOSITE OF CARDIAC DEATH, TARGET-VESSEL MYOCARDIAL INFARCTION AND ISCHEMIC-DRIVEN TARGET LESION REVASCULARIZATION. PATIENTS WERE ON DAPT. VESSELS TREATED WERE LAD, LCX, RCA AND LEFT MAIN. AT 6-MONTHS FOLLOW-UP CLINICAL OUTCOMES REPORTED WERE CARDIAC DEATH, TARGET-VESSLE MYOCARDIAL INFARCTION AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443275 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention