BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7109143 · Received December 12, 2017

    Report

    Report Number
    9612164-2017-01888
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 22, 2016
    Report Date
    December 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL NAME: KOREAN CIRCULATION JOURNAL TITLE OF ARTICLE: IMPACT OF CHRONIC KIDNEY DISEASE ON CLINICAL OUTCOMES IN DIABETIC PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION IN THE ERA OF NEWER-GENERATION DRUG-ELUTING STENTS LITERATURE REFERENCE: DOI.ORG/10.4070/KCJ.2016.0312 RECEIVED: DECEMBER 23, 2016. REVISED: MARCH 2, 2017. ACCEPTED: MARCH 9, 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TOTAL OF 887 PATIENTS WHO UNDERWENT PCI WITH NEWER-GENERATION DES AND WHO HAD A HISTORY OF DIABETES MELLITUS AT THE TIME OF HOSPITALIZATION WERE ANALYZED. THESE PATIENTS WERE DIVIDED INTO GROUPS WITHOUT CHRONIC KIDNEY DISEASE (N=549) AND WITH CHRONIC KIDNEY DISEASE (N=338). 276 PATIENTS IN THIS STUDY HAD ENDEAVOR RESOLUTE DRUG ELUTING STENT AND/OR RESOLUTE INTEGRITY IMPLANTED IN THE LAD, LCX, RCA OR LM. PATIENTS UNDERWENT PCI ACCORDING TO STANDARDIZED METHODS. THE DECISION FOR PRE-DILATATION OR DIRECT STENTING WERE MADE AT THE DISCRETION OF THE OPERATING PHYSICIANS. AFTER THE INDEX PROCEDURE, AN ASPIRIN DOSAGE OF 100 MG WAS PRESCRIBED PERMANENTLY, AND A 75-MG DOSAGE OF CLOPIDOGREL (INTERCHANGEABLE WITH PRASUGREL IN A DOSAGE OF 10 MG DAILY OR TICAGRELOR IN A DOSAGE OF 90 MG TWICE DAILY) WAS PRESCRIBED FOR AT LEAST ONE YEAR. CLINICAL FOLLOW UP WAS PERFORMED AT 6 AND 12 MONTHS FOLLOWING PCI AND MAJOR CLINICAL EVENTS REPORTED INCLUDED DEATH(CARDIAC AND NON CARDIAC), MYOCARDIAL INFARCTION, REVASCULARIZATION(TARGET LESION AND TARGET VESSEL) AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888121 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention