BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7994578 · Received October 23, 2018

    Report

    Report Number
    9612164-2018-02877
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    June 15, 2017
    Report Date
    October 23, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPACT OF PCI APPROPRIATENESS IN THE LONG-TERM OUTCOMES OF CONSECUTIVE PATIENTS TREATED WITH SECOND-GENERATION DRUG-ELUTING STENTS. AUTHORS: ANA CRISTINA SEIXAS, AMANDA SOUSA, JOSE DE RIBAMAR COSTA, JR, ADRIANA COSTA MOREIRA, RICARDO COSTA, LUCAS DAMIANI, CANTÍDIO CAMPOS NETO, GALO MALDONADO, MANUEL CANO, J. EDUARDO SOUSA. JOURNAL: JOURNAL OF INVASIVE CARDIOLOGY ISSUE: 2017; 29 (9): 290-296. EPUB 2017 JUNE 15. REF: J INVASIVE CARDIOL 2017; 29 (9): 290-296. AVERAGE AGE. MAJORITY GENDER. DATE ARTICLE PUBLISHED ONLINE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED THAT REPORTED THE LONG-TERM OUTCOMES OF CONSECUTIVE PATIENTS TREATED WITH SECOND-GENERATION DRUG-ELUTING STENTS. PATIENTS PRESENTED WITH SILENT ISCHEMIA, STABLE ANGINA, "UNABLE" ANGINA OR MYOCARDIAL INFARCTION AND UNDERWENT PCI WITH SECOND-GENERATION DES IMPLANTATION. RESOLUTE INTEGRITY DES WERE IMPLANTED IN THE POPULATION. CLINICAL EVENTS REPORTED OVER 3 YEAR FOLLOW UP WERE DEATH, MYOCARDIAL INFARCTION, TARGET-LESION REVASCULARIZATION AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835447 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention