BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7984966 · Received October 19, 2018

    Report

    Report Number
    9612164-2018-02837
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    May 30, 2017
    Report Date
    October 19, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE, AGE, MAJORITY, GENDER, DATE OF PUBLICATION CORONARY ARTERY BYPASS SURGERY VERSUS PERCUTANEOUS CORONARY INTERVENTION FOR LEFT MAIN CORONARY ARTERY DISEASE WITH CHRONIC KIDNEY; DOI: 10.1536/IHJ.17-260. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM (B)(6) 2004 TO (B)(6) 2010, 185 PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE AND CHRONIC KIDNEY DISEASE UNDERGOING PCI (N = 84) OR CABG (N = 101) WERE ENROLLED IN A STUDY. MEDTRONIC ZOTAROLIMUS ELUTING STENTS WERE AMONG THE DES IMPLANTED. CLINICAL OUTCOMES REPORTED WERE DEATH, STENT THROMBOSIS, STROKE REPEAT REVASCULARIZATION AND MYOCARDIAL INFRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827428 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization