BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 11122449 · Received January 6, 2021

    Report

    Report Number
    9612164-2021-00031
    Event Type
    Injury
    Date Received
    January 6, 2021
    Date of Event
    February 6, 2020
    Report Date
    January 6, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: PROSPECTIVE PARTIALLY RANDOMIZED COMPARISON OF CLOPIDOGREL LOADING VERSUS MAINTENANCE DOSING TO PREVENT PERIPROCEDURAL MYOCARDIAL INFARCTION AFTER STENTING FOR STABLE ANGINA PECTORIS AUTHORS: JAE HYOUNG PARK, JE SANG KIM, CHUL-MIN AHN, SOON JUN HONG, KYUNG JOO AHN, JAE WOONG CHOI, HYUNG JOON JOO, CHEOL WOONG YU, AND DO-SUN LIM JOURNAL: INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS YEAR: 2020 REFERENCE: DOI 10.5414/CP203644. 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. THE AIM OF THE STUDY WAS TO EVALUATE THE PRE-TREATMENT METHODS FOR PREVENTING PERIPROCEDURAL MYOCARDIAL INFARCTION (PMI) AMONG PATIENTS UNDERGOING CONVENTIONAL CORONARY ANGIOGRAPHY (CAG) FOR STABLE ANGINA PECTORIS. ENDEAVOR RESOLUTE, RESOLUTE INTEGRITY, ENDEAVOR RX AND DRIVER RX CORONARY STENTS WERE AMONG THE DEVICES USED. CLINICAL OUTCOMES REPORTED INCLUDED DEATH, PERIPROCEDURAL MYOCARDIAL INFARCTION, BLEEDING, STENT THROMBOSIS AND REVASCULARIZATION. IT WAS STATED THAT ONE CASE OF CARDIAC DEATH OCCURRED DUE TO RECURRENT REFRACTORY STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19577 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention