BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7999029 · Received October 24, 2018

    Report

    Report Number
    9612164-2018-02901
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    February 6, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH=AVERAGE AGE. SEX= MAJORITY GENDER. DATE OF EVENT=DATE OF PUBLICATION. MID-TO-LONG TERM MORTALITY FOLLOWING SURGICAL VERSUS PERCUTANEOUS CORONARY REVASCULARIZATION STRATIFIED ACCORDING TO STENT SUBTYPE: AN ANALYSIS OF 6,682 PATIENTS WITH MULTIVESSEL DISEASE HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0191554. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL WAS RECEIVED FOR REVIEW. AN OBSERVATIONAL COHORT OF CONSECUTIVE PATIENTS TREATED WITH PCI AND CABG BETWEEN 2004 AND 2015 WAS EXAMINED. THE STUDY WAS TO EVALUATE MID-TO-LONG TERM MORTALITY FOLLOWING SURGICAL VERSUS PERCUTANEOUS CORONARY REVASCULARIZATION STRATIFIED ACCORDING TO STENT SUBTYPE. 6,682 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS (4,388 PATIENTS IN THE CABG GROUP AND 2,294 PATIENTS IN THE PCI GROUP).A TOTAL OF 377 PATIENTS RECEIVED PACLITAXEL- ELUTING STENTS (PES), 475 PATIENTS RECEIVED SIROLIMUS-ELUTING STENTS (SES), 286 PATIENTS RECEIVED EVEROLIMUS-ELUTING STENTS (EES) AND 922 PATIENTS RECEIVED MEDTRONIC ZOTAROLIMUS-ELUTING STENTS (ZES). MORTALITY OUTCOMES WERE ASSESSED OVER 30 DAYS, 1 YEAR, 3 YEAR AND 5 YEARS. IT WAS FOUND THAT EES AND ZES HAD COMPARABLE MORTALITY COMPARED TO CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839823 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death