BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 10487871 · Received September 3, 2020

    Report

    Report Number
    9612164-2020-03321
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    July 29, 2019
    Report Date
    September 3, 2020
    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

    JOURNAL ARTICLE: COMPARISON OF 9-MONTH ANGIOGRAPHIC FOLLOW-UP AND LONG-TERM CLINICAL OUTCOMES OF BIODEGRADABLE POLYMER DRUG-ELUTING STENTS AND SECOND -GENERATION DURABLE POLYMER DRUG-ELUTING STENTS IN PATIENTS UNDERGOING SINGLE CORONARY ARTERY STENTING AUTHORS: MING-LUNG TSAI, MING-JER HSIEH, CHUN-CHI CHEN, SHANG-HUNG CHANG, CHAO-YUNG WANG, DONG-YI CHEN, CHIA-HUNG YANG, JIH-KAI YEH, MING-YUN HO AND I-CHANG HSIEH JOURNAL: ACTA CARDIOLOGICA SINICA YEAR: 2020 REFERENCE: DOI: 10.6515/ACS.202003_36(2).20190729A. THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC DEVICE. AGE AT TIME OF EVENT: AVERAGE AGE. SEX: MAJORITY GENDER. DATE OF EVENT: 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 TITLED "COMPARISON OF 9-MONTH ANGIOGRAPHIC FOLLOW-UP AND LONG-TERM CLINICAL OUTCOMES OF BIODEGRADABLE POLYMER DRUG-ELUTING STENTS AND SECOND-GENERATION DURABLE POLYMER DRUG-ELUTING STENTS IN PATIENTS UNDERGOING SINGLE CORONARY ARTERY STENTING" WAS SUBMITTED. THE AIM OF THE STUDY WAS TO ELUCIDATE THE ANGIOGRAPHIC AND CLINICAL DIFFERENCES BETWEEN SECOND-GENERATION DP-DESS AND BP-DESS IN AN EAST ASIAN POPULATION. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE TYPE OF STENTS THEY WERE TREATED WITH, 367 WERE TREATED WITH DP-DES AND 69 PATIENTS WERE TREATED WITH BP-DES. RESOLUTE INTEGRITY DRUG ELUTING STENTS WERE AMONG THOSE USED IN THE SECOND GENERATION DP DES GROUP. CLINICAL OUTCOMES INCLUDED CARDIAC DEATH, RESTENOSIS, MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR) AND ALL REVASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952338 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention