BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7236707 · Received February 2, 2018

    Report

    Report Number
    9612164-2018-00193
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    July 9, 2015
    Report Date
    February 2, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF PUBLICATION ONLINE BARE METAL STENTS VERSUS DRUG ELUTING STENTS: WHERE DO WE STAND IN 2015? CURR TREAT OPTIONS CARDIOVASC MED DOI: 10.1007/S11936-015-0393-Y . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS ARTICLE WAS TO REVIEW RETROSPECTIVELY VARIOUS STUDIES ON THE USE OF BARE METAL STENT AND DRUG ELUTING STENT. IT REVIEW VARIOUS COMPARISON STUDIES AND TRIALS, REPORTING THE VARIOUS ADVERSE EVENT OUTCOMES FROM SUCH TRIAL OR STUDY. THE ENDEAVOR TRIALS WHICH COMPARED ZOTAROLIMUS TO PACLITAXEL DRUG ELUTING STENT, REPORTED SIGNIFICANT DIFFERENCES IN DEATH, MYOCARDIAL INFARCTION AND COMPOSITE END POINTS THAT FAVOURED ZOTAROLIMUS. ALSO REPORTED IS THE EXCELLENT AND RESOLUTE-(B)(6) REGISTRIES WHERE PATIENTS RECEIVED EITHER RESOLUTE INTEGRITY OR EVEROLIMUS, THE INDICATIONS REVEALED SIMILAR RESULTS. IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT DIFFERENCE IN THE RATE OF THE PRIMARY COMBINED OUTCOMES AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81381 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1