BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7968915 · Received October 16, 2018

    Report

    Report Number
    9612164-2018-02759
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    May 25, 2018
    Report Date
    October 16, 2018
    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

    TITLE: IMPACT OF OUT-STENT PLAQUE CHARACTERISTICS ON VASCULAR RESPONSE AFTER SECOND GENERATION DRUG-ELUTING STENT IMPLANTATION: IMAP -INTRAVASCULAR ULTRASOUND AND ANGIOSCOPIC STUDY. AUTHORS: KENJI KAWAI, MINORU ICHIKAWA, TOHRU MASUYAMA, MASAHARU ISHIHARA, YOSHIYUKI KIJIMA. JOURNAL: IJC HEART: VASCULATURE ISSUE: 19 (2018) 83¿87. REF: DOI.ORG/10.1016/J.IJCHA.2018.05.004. AVERAGE AGE. MAJORITY GENDER. DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW. PATIENTS WITH CORONARY ARTERY DISEASE WERE ENROLLED INTO THE STUDY AND UNDERWENT 2ND GENERATION DES IMPLANTATION. RESOLUTE ZOTAROLIMUS-ELUTING STENTS ALONG WITH OTHER NON-MEDTRONIC STENTS WERE IMPLANTED IN PATIENTS. LESIONS TREATED INCLUDED RCA, LAD AN LCX. TWO PATIENTS WERE WITHDRAWN FROM FOLLOW-UP DUE TO STROKE AND NON-CARDIAC DEATH. ONE PATIENT SUFFERED INSTENT RESTENOSIS. ONE YEAR POST IMPLANT POOR NEOINTIMAL STENT COVERAGE (NSC) WAS FOUND IN A PERCENTAGE OF IMPLANTED STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811138 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR