BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 7784174 · Received August 15, 2018

    Report

    Report Number
    9612164-2018-02060
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    June 11, 2018
    Report Date
    August 15, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPACT OF HYPERURICEMIA ON CLINICAL OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION FOR IN-STENT RESTENOSIS AUTHORS: HYUNG JOON JOO, HAN SAEM JEONG, HYUNGDON KOOK, SEUNG HUN LEE, JAE HYOUNG PARK, SOON JUN HONG, CHEOL WOONG YU AND DO-SUM LIM JOURNAL: BMC CARDIOVASCULAR DISORDERS ISSUE: (2018) 18:114 REF: HTTPS://DOI.ORG/10.1186/S12872-018-0840. 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 THAT 317 PATIENTS WERE STUDIED IN RELATION TO THE IMPACT OF HYPERURICEMIA ON CLINICAL OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION FOR IN-STENT RESTENOSIS. A SELECTION OF THE PARTICIPANTS WERE TREATED WITH MEDTRONIC ENDEAVOR STENTS. ADVERSE EVENTS REPORTED IN THE ARTICLE INCLUDED DEATH, NON-FATAL MYOCARDIAL INFARCTION, TARGET VESSEL REVASCULARIZATION AND NON-TARGET VESSEL REVASCULARIZATION, CABG, STENT THROMBOSIS AND IN-STENT RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628748 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention