BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8797779 · Received July 17, 2019

    Report

    Report Number
    9612164-2019-02907
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    April 10, 2019
    Report Date
    July 17, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JOURNAL ARTICLE:EFFECTIVENESS AND SAFETY OF ZOTAROLIMUS-ELUTING STENT (RESOLUTE¿ INTEGRITY) IN PATIENTS WITH DIFFUSE LONG CORONARY ARTERY DISEASE. TITLE: JOURNAL: KOREAN CIRCULATION JOURNAL YEAR: 2019 REF: HTTPS://DOI.ORG/10.4070/KCJ.2019.0018. DATE OF PUBLICATION ADDITIONAL INFORMATION: DAPT - CLOPIDOGREL AND ASPIRIN. PRASUGREL OR TICAGRELOR. THERE IS NO INFORMATION TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC DEVICE. 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 SELECTION OF PATIENTS IN A STUDY RECEIVED RESOLUTE INTEGRITY RX (R-ZES) AND ENDEAVOUR RESOLUTE DRUG ELUTING STENTS AND NON MEDTRONIC STENTS. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE EFFECTIVENESS AND SAFETY OF RESOLUTE INTEGRITY RX IN PATIENTS WITH DLCAD, A PARTICULARLY LONG LESION =25 MM. ANTIPLATELETS MEDICATION WERE ADMINISTERED TO ALL PATIENTS PRIOR TO THE INDEX PROCEDURE. ADVERSE EVENTS EXPERIENCED INCLUDED BLEEDING COMPLICATION, CVA, STENT THROMBOSIS, CARDIAC DEATH, NON-FATAL MI, MACE (DEFINED AS THE COMPOSITE OF CARDIAC DEATH, NON-FATAL MYOCARDIAL INFARCTION (MI), DEFINITE STENT THROMBOSIS (ST), AND CLINICALLY-DRIVEN TARGET VESSEL REVASCULARIZATION (TVR) AT 12-MONTH FOLLOW-UP), TARGET LESION REVASCULARIZATION, TARGET AND NONTARGET VESSEL REVASCULARIZATION. THE INCIDENCE OF TVR AND MACE WERE RELATIVELY LOW AND THAT OF DEFINITE ST WAS RARE AT 12-MONTH FOLLOW UP. THEREFORE, THE STUDY DEMONSTRATED THAT R-ZES HAD AN EXCELLENT 1-YEAR CLINICAL OUTCOME IN STUDY PATIENTS WITH DLCAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593621 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R