BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 12084586 · Received June 29, 2021

    Report

    Report Number
    9612164-2021-02522
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    September 11, 2020
    Report Date
    June 29, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: DIFFERENCES IN LESION CHARACTERISTICS AND PATIENT BACKGROUND ASSOCIATED WITH THE MEDIUM-TERM CLINICAL OUTCOMES OF B ARE-METAL AND FIRST-, SECOND- AND THIRD-GENERATION DRUG-ELUTING STENTS AUTHORS: MASAYUKI NAKAMURA, AMANE IKE, YUTA KATO, MAKITO FUTAMI, TAKASHI KUWANO, MAKOTO SUGIHARA, ATSUSHI IWATA, AKIRA KAWAMURA, YASUNORI SUEMATSU, SHIN-ICHIRO MIURA JOURNAL: HEART AND VESSELS YEAR: 2021 REFERENCE: DOI.ORG/10.1007/S00380-020-01692-Z PATIENT DEATHS WERE ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICES USED IN THE PATIENT COHORT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS WAS PROVIDED. 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

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¿9 MONTHS AFTER PCI, HOWEVER, ONLY 70% OF PATIENTS P ARTICIPATED. FOR PATIENTS WHO WERE UNABLE TO UNDERGO FOLLOW-UP CAG, CLINICAL OUTCOMES WERE INVESTIGATED THROUGH OUTPATIENT CONSULTATION AND TELEPHONE CONTACT. THE INCIDENCE OF MACES WAS SEEN IN ALL STUDY GROUPS AS WELL AS IN-STENT RESTENOSIS, STENT LATE LUMEN LOSS AND STENT THROMBOSIS. MACES WAS SIGNIFICANTLY HIGHER IN THE BMS GROUP THAN THOSE IN THE 1ST, 2ND AND 3RD DES GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984215 RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention