BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7999374 · Received October 24, 2018

    Report

    Report Number
    9612164-2018-02909
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    August 28, 2017
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: DATE OF PUBLICATION. IMPACT OF ASPIRIN AND CLOPIDOGREL HYPORESPONSIVENESS IN PATIENTS TREATED WITH DRUG-ELUTING STENTS. HTTP://DX.DOI.ORG/10.1016/J.JCIN .2017.05 .059. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE JOURNAL WAS TO ASSESS THE IMPACT OF ASPIRIN AND CLOPIDOGREL HYPORESPONSIVENESS IN PATIENTS TREATED WITH DRUG-ELUTING STENTS. MEDTRONIC ZOTAROLIMUS ELUTING STENTS WERE AMONG THE DRUG ELUTING STENTS IMPLANTED. 8,582 PATIENTS WERE ENROLLED BETWEEN 2008 AND 2010. CLINICAL OUTCOMES REPORTED WERE STENT THROMBOSIS, MYOCARDIAL INFARCTION, BLEEDING AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839547 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASPIRIN AND CLOPIDOGREL