BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6306986 · Received February 7, 2017

    Report

    Report Number
    9612164-2017-00113
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    November 26, 2016
    Report Date
    January 16, 2017
    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

    JOURNAL NAME: LANCET ISSUE: LANCET 2016; 388: 2607¿17 ARTICLE NAME: VERY THIN STRUT BIODEGRADABLE POLYMER EVEROLIMUS-ELUTING AND SIROLIMUS-ELUTING STENTS VERSUS DURABLE POLYMER ZOTAROLIMUS-ELUTING STENTS IN ALLCOMERS WITH CORONARY ARTERY DISEASE (BIO-RESORT): A THREE-ARM, RANDOMISED, NON-INFERIORITY TRIAL. REF: HTTP://DX.DOI.ORG/10.1016/ S0140-6736(16.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A STUDY WAS CARRIED OUT INVOLVING RESOLUTE INTEGRITY DRUG ELUTING STENTS VS TWO NON-MDT BRAND DEVICES. VESSELS TREATED IN THE STUDY USING RESOLUTE INTEGRITY DRUG ELUTING STENTS INCLUDED LEFT MAIN STEM, LAD, LCX, RCA, BYPASS GRAFT. LESION CHARACTERISTICS INCLUDED CHRONIC TOTAL OCCLUSION, IN-STENT RESTENOSIS, BIFURCATION AND SEVERE CALCIFICATION. ADVERSE EVENTS RELATED TO PATIENTS WITH RESOLUTE INTEGRITY DRUG ELUTING STENTS INCLUDE DEATH INCLUDING CARDIAC DEATH, MI, TVR, TLR <(>&<)> STENT THROMBOSIS .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89490 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention