BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8435297 · Received March 20, 2019

    Report

    Report Number
    9612164-2019-00934
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    October 13, 2018
    Report Date
    March 20, 2019
    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

    LITERATURE REFERENCE: DOI: 10.1253/CIRCJ.CJ-18-0672. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS WAS A RETROSPECTIVE MULTICENTER STUDY (RETROSPECTIVE COMPARISON OF LONG-TERM CLINICAL OUTCOMES BETWEEN PERCUTANEOUS CORONARY INTERVENTION AND MEDICAL THERAPY IN STABLE CORONARY ARTERY DISEASE WITH GRAY ZONE FRACTIONAL FLOW RESERVE (FFR)). BETWEEN JUNE 2005 AND DECEMBER 2016, PATIENTS WITH FFR 0.75¿0.80 IN A NATIVE CORONARY ARTERY WERE IDENTIFIED. THE PATIENTS WITH FFR 0.75¿0.80 WERE CATEGORIZED INTO 2 GROUPS ACCORDING TO THE THERAPEUTIC APPROACH TO THE TARGET CORONARY ARTERY: PCI USING DES (PCI GROUP) OR MEDICAL THERAPY (MEDICAL THERAPY GROUP). PCI WAS PERFORMED IN THE STANDARD MANNER USING A DES. THE PATIENTS WHO UNDERWENT PCI WERE TREATED WITH ASPIRIN AND ANOTHER ANTIPLATELET AGENT SUCH AS CLOPIDOGREL OR PRASUGREL FOR AT LEAST 6 MONTHS AFTER PCI. THE PRIMARY ENDPOINT WAS TARGET VESSEL FAILURE (TVF), DEFINED AS A COMPOSITE OF CARDIAC DEATH, MI AND ISCHEMIA-DRIVEN TARGET VESSEL REVASCULARIZATION( TVR). SECONDARY ENDPOINTS INCLUDED THE INDIVIDUAL COMPONENTS OF THE PRIMARY ENDPOINT, A COMPOSITE OF CARDIAC DEATH OR MI; CLINICALLY-DRIVEN TVR; URGENT TVR; AND STROKE. 263 PATIENTS CONSTITUTED THE FINAL STUDY POPULATION: 78 PATIENTS IN THE PCI GROUP AND 185 PATIENTS IN THE MEDICAL THERAPY GROUP. 1 RESOLUTE INTEGRITY (MEDTRONIC) WAS USED IN THE PCI GROUP. THE MEDIAN FOLLOW-UP PERIOD IN THE PCI AND MEDICAL THERAPY GROUPS WAS 3.0 YEARS AND 3.9 YEARS. CLINICAL OUTCOMES IN THE PCI GROUP INCLUDED TVF, CARDIAC DEATH, MI, ISCHEMIA AND CLINICALLY DRIVEN TVR, URGENT TVR AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228823 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention