BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7952440 · Received October 10, 2018

    Report

    Report Number
    9612164-2018-02699
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    May 3, 2017
    Report Date
    October 10, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: EFFECTS OF QISHEN YIQI DRIPPING PILLS IN REDUCING MYOCARDIAL INJURY AND PRESERVING MICROVASCULAR FUNCTION IN PATIENTS UNDERGOING ELECTIVE PERCUTANEOUS CORONARY INTERVENTION: A PILOT RANDOMIZED STUDY. AUTHORS: HE GUI-XIN, XIE JUN, JIANG HAO, TAN WEI, AND XU BIAO. PUBLICATION: CHIN J INTEGR MED ISSUE #: MAR; 24 (3): 193-199. YEAR OF PUBLICATION: 2018. LITERATURE REFERENCE: DOI.ORG/10.1007/S11655-017-2955-1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RESOLUTE INTEGRITY DRUG ELUTING STENT DEVICES WERE USED IN PROCEDURES TO TREAT LESIONS IN THE LAD, LCX AND RCA. SIDE BRANCH OCCLUSION IS REPORTED TO HAVE OCCURRED IN NINE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793390 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other