BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 10013081 · Received April 30, 2020

    Report

    Report Number
    9612164-2020-01727
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    March 24, 2020
    Report Date
    June 30, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF PUBLICATION. JOURNAL ARTICLE TITLE: EVEROLIMUS-ELUTING XIENCE PRIME/X PEDITION VERSUS ZOTAROLIMUS-ELUTING RESOLUTE INTEGRITY STENTS IN PATIENTS WITH DIABETES MELLITUS AND SMALL VESSEL DISEASE. LITERATURE REFERENCE: 10.1016/S0735-1097(20)32128-8. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT AGE AND WEIGHT. IT WAS STATED THAT THERE WERE NO CAUSAL RELATIONSHIP BETWEEN THE RESOLUTE INTEGRITY DEVICES AND ANY OF THE CARDIAC DEATHS REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY SOUGHT TO COMPARE NON-MEDTRONIC EVEROLIMUS-ELUTING STENTS (EES) VERSUS RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING STENTS (ZES) IN TERMS OF PATIENT- OR STENT-RELATED CLINICAL OUTCOMES WITH DIABETES MELLITUS (DM) OR SMALL VESSEL DISEASE. PATIENTS WITH DIABETES MELLITUS (432 PATIENTS) OR UNDERGOING PCI OF SMALL CORONARY VESSELS (=2.75 MM) (278 PATIENTS) WERE RANDOMISED TO EES (N=302) OR ZES (N=298). CLINICAL OUTCOMES REPORTED AT 2 YEAR FOLLOWUP INCLUDED PRIMARY ENDPOINT OF TARGET LESION REVASCULARIZATION (TLR), SECONDARY ENDPOINTS OF MAJOR ADVERSE CARDIAC EVENTS (MACE); A COMPOSITE OF CARDIAC DEATH, ANY MYOCARDIAL INFARCTION (MI), TLR AND STENT THROMBOSIS. THE STUDY CONCLUDED THAT AFTER UNRESTRICTED USE OF SECOND-GENERATION DRUG-ELUTING STENTS IN ALL-COMERS RECEIVING PERCUTANEOUS CORONARY INTERVENTION, BOTH EES AND ZES SHOWED COMPARABLE CLINICAL OUTCOMES IN THE PATIENTS WITH DM AND SMALL VESSEL PCI UP TO 2 YEAR OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478920 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention