BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7684713 · Received July 13, 2018

    Report

    Report Number
    9612164-2018-01717
    Event Type
    Death
    Date Received
    July 13, 2018
    Date of Event
    May 23, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: TWO-YEAR CLINICAL OUTCOME OF ALL-COMERS TREATED WITH THREE HIGHLY DISSIMILAR CONTEMPORARY CORONARY DRUG-ELUTING STENTS IN THE RANDOMISED BIO-RESORT TRIAL AUTHORS: MARLIES M. KOK, MD; PAOLO ZOCCA, MD; ROSALY A. BUITEN, MD; PETER W. DANSE, MD, PHD; CARL E. SCHOTBORGH, MD; MARTIJN SCHOLTE, MD; MARC HARTMANN, MD, PHD; MARTIN G. STOEL, MD, PHD; K. GERT VAN HOUWELINGEN, MD; GERARD C.M. LINSSEN, MD, PHD; CARINE J.M. DOGGEN, PHD; CLEMENS VON BIRGELEN, MD, PHD JOURNAL: EUROINTERVENTION YEAR:2018 ISSUE: 14 REF: DOI: 10.4244/EIJ-D-18-00336. AGE/DATE OF BIRTH=AVERAGE AGE. SEX= MAJORITY GENDER. DATE OF EVENT=DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS IMPLANTED IN 1,173 PATIENTS IN THE STUDY POPULATION. PATIENTS WERE ON DAPT FOR 12-MONTHS AND FOLLOWED A STRINGENT DAPT DISCONTINUATION POLICY AFTER ONE YEAR. THE PRIMARY COMPOSITE ENDPOINT OF TARGET VESSEL FAILURE (TVF) ASSESSED DEVICE EFFICACY AND PATIENT SAFETY AND CONSISTED OF CARDIAC DEATH, TARGET VESSEL-RELATED MYOCARDIAL INFARCTION (MI), OR CLINICALLY INDICATED TARGET VESSEL REVASCULARISATION. SECONDARY ENDPOINTS INCLUDED: TARGET LESION REVASCULARISATION (TLR), TARGET LESION FAILURE (TLF, A COMPOSITE OF CARDIAC DEATH, ANY MI NOT CLEARLY ATTRIBUTABLE TO A NON-TARGET VESSEL, OR CLINICALLY DRIVEN TLR), MAJOR ADVERSE CARDIAC EVENTS (MACE, A COMPOSITE OF ALL-CAUSE DEATH, ANY MI, OR EMERGENT CORONARY BYPASS SURGERY, OR REPEAT CLINICALLY INDICATED TLR), THE MOST GLOBAL PATIENT-ORIENTED COMPOSITE ENDPOINT (POCE, A COMPOSITE OF ALL-CAUSE DEATH, ANY MI, OR ANY REPEAT CORONARY REVASCULARISATION), AND DEFINITE-OR-PROBABLE STENT THROMBOSIS. DURING FOLLOW-UP, CLINICAL EVENTS REPORTED IN PATIENTS TREATED WITH RESOLUTE INTEGRITY ZES WERE DEATH, MYOCARDIAL INFARCTION, REVASCULARIZATION AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529680 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death