BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 9871093 · Received March 24, 2020

    Report

    Report Number
    9612164-2020-01323
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    December 13, 2019
    Report Date
    March 24, 2020
    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

    LIT REF: 10.1253/CIRCJ.CJ-19-0667. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF GUIDELINE-RECOMMENDED RISK SCORE-DIRECTED DUAL ANTIPLATELET THERAPY (GD-DAPT) BASED ON THE PRECISE-DAPT SCORE AFTER 2ND-GENERATION DRUG-ELUTING STENT (DES) IMPLANTATION. DATA OF 5,131 PATIENTS POOLED FROM 4 RANDOM STUDY POPULATIONS WHO WERE TREATED WITH 2ND-GENERATION DES WERE INCLUDED IN THE FINAL STUDY POPULATION. THE FOUR RANDOMISED STUDIES PATIENT DATA WAS POOLED FROM WERE THE IVUS-XPL, RESET, OPTIMA-C AND EXCELLENT TRIALS. 2,117 PATIENTS INCLUDED IN THE RESET TRIAL WERE TREATED WITH A RESOLUTE ZOTAROLIMUS DES OR A ENDEAVOR ZOTAROLIMUS DES. PATIENTS WERE DIVIDED INTO 3 GROUPS ACCORDING TO CURRENT RECOMMENDATIONS ON THE DURATION OF DAPT AND THEIR ACTUAL DAPT DURATION. A LL THREE OF THESE GROUPS CONSISTED OF A NUMBER OF PATIENTS IMPLANTED WITH A ENDEAVOR ZOTAROLIMUS DES. PATIENTS IMPLANTED WITH RESOLUTE ZOTAROLIMUS DES WERE INCLUDED IN THE GD-DAPT AND LONGER DAPT GROUPS BUT NOT THE SHORTER DAPT GROUP. THE PRIMARY ENDPOINT WAS THE RATE OF NET ADVERSE CLINICAL EVENTS (NACE) DURING THE FIRST 12 MONTHS. THE SECONDARY ENDPOINTS WERE ISCHEMIC OR BLEEDING EVENTS. NACE COMPRISED OF CARDIAC DEATH, MYOCARDIAL INFARCTION (MI), ST, STROKE, OR MAJOR BLEEDING DURING THE FIRST 12 MONTHS. CLINICAL OUTCOMES IN THE STUDY POPULATION INCLUDED CARDIAC DEATH, MYOCARDIAL INFARCTION (MI), STENT THROMBOSIS (ST), STROKE, BLEEDING AND ISCHEMIA-DRIVEN TARGET VESSEL REVASCULARIZATION (TVR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338347 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention