BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7995569 · Received October 23, 2018

    Report

    Report Number
    9612164-2018-02887
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    July 5, 2017
    Report Date
    October 23, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    0702798353
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF PUBLICATION JOURNAL ARTICLE TITLE: IMPACT OF KILLIP CLASSIFICATION ON ACUTE MYOCARDIAL INFARCTION: DATA FROM THE SAIKUMA REGISTRY EIJI TAGUCHI1 · YUTAKA KONAMI1 · MASAYUKI INOUE1 · HIROTO SUZUYAMA1 · KAZUHISA KODAMA1 · MASAYOSHI YOSHIDA1 · SHINZO MIYAMOTO1 · KOICHI NAKAO1 · TOMOHIRO SAKAMOTO1 HEART VESSELS (2017) 32:1439¿1447 DOI 10.1007/S00380-017-1017-0. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT THERAPEUTIC DEVICES FOR ACUTE MYOCARDIAL INFARCTION (AMI) HAVE EVOLVED DRAMATICALLY IN RECENT YEARS. HOWEVER, THE IMPACT OF THE KILLIP CLASSIFICATION OF AMI OUTCOMES IN PATIENTS UNDERGOING AGGRESSIVE PERCUTANEOUS CORONARY INTERVENTION REMAINS UNCLEAR. WE PERFORMED A 10-YEAR RETROSPECTIVE REVIEW OF 2062 PATIENTS DIAGNOSED WITH AMI, AND DIVIDED THE DATA INTO TWO 5-YEAR INTERVALS: 2005¿2009 (N = 1071), AND 2010¿2014 (N = 991). NO DIFFERENCE WAS OBSERVED IN IN-HOSPITAL MORTALITY RATE BETWEEN THE TWO PERIODS (FIRST PERIOD, 11.5% VS SECOND PERIOD, 9.7%; P = 0.19). THE INCIDENCE OF STENT THROMBOSIS WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO PERIODS, AND VERY FEW THROMBI OCCURRED IN PATIENTS WHO RECEIVED SECOND-GENERATION DRUG-ELUTING STENTS (DES) (0.98%: 5/511). IN-HOSPITAL MORTALITY DUE TO STENT THROMBOSIS WAS HIGH IN THE FULL COHORT (15%). DURING THE SECOND PERIOD, IN-HOSPITAL MORTALITY WAS LOWER IN KILLIP CLASS 4 PATIENTS, ALTHOUGH THE DIFFERENCE WAS NOT SIGNIFICANT (59.1 VS 47.5%, P = 0.07). MULTIVARIABLE LOGISTIC REGRESSION IDENTIFIED SEVERAL FACTORS THAT SIGNIFICANTLY AFFECTED IN-HOSPITAL MORTALITY, INCLUDING AGE [ODDS RATIO (OR) 1.07], LEFT MAIN TRUNK (OR 2.47), PEAK CPK VALUE ABOVE 5000 IU/L (OR 3.18), AND KILLIP CLASS 4 (OR 15.63). WE EVALUATED TRENDS IN IN-HOSPITAL MORTALITY AMONG PATIENTS WITH AMI OVER A 10-YEAR PERIOD. NEW DES AND THE FREQUENT USE OF MECHANICAL SUPPORT IN PATIENTS WITH HEMODYNAMIC COMPROMISE TENDED TO IMPROVE IN-HOSPITAL MORTALITY, BUT THE EFFECT WAS NOT SIGNIFICANT. NOTABLY, KILLIP CLASS 4 ON ADMISSION WAS ASSOCIATED WITH AN ESTIMATED 16-FOLD INCREASED RISK OF IN-HOSPITAL DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836035 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention