BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 10256614 · Received July 10, 2020

    Report

    Report Number
    9612164-2020-02518
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    December 21, 2019
    Report Date
    July 10, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY AIMS TO EVALUATE THE RELATIONSHIP OF QUANTITATIVE CORONARY ANALYSIS-BASED QUANTITATIVE FLOW RATIO (QFR) AFTER SECOND-GENERATION DRUG-ELUTING STENT (2ND GEN-DES) IMPLANTATION TO CLINICAL OUTCOMES. 52 LESIONS OF 45 PATIENTS WERE ANALYZED IN THIS STUDY FROM OCTOBER 2014 TO DECEMBER 2015. FOUR TYPES OF 2ND GEN-DES WERE AVAILABLE FOR USE IN THE STUDY. RESOLUTE INTEGRITY STENTS WERE ONE OF THE TYPES USED IN THE STUDY POPULATION. CLINICAL OUTCOMES REPORTED INCLUDED DEATH, MYOCARDIAL INFARCTION, AND CLINICALLY-DRIVENTARGET VESSEL REVASCULARIZATION (TVR) WHICH INCLUDED TARGET VESSEL PCI AND BYPASS SURGERY OF THE TARGET VESSEL PERFORMED IN THE POPULATION AT 68 YEARS. THE FOLLOW-UP PERIOD WAS AT LEAST 18¿30 MONTHS. DEATH WAS DEFINED AS ALL-CAUSE MORTALITY. OF 52 LESIONS, TVR WAS PERFORMED IN EIGHT LESIONS. TVR OCCURRED IN ONE PATIENT IMPLANTED WITH A RESOLUTE INTEGRITY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725223 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention