BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8208179 · Received January 2, 2019

    Report

    Report Number
    9612164-2019-00010
    Event Type
    Death
    Date Received
    January 2, 2019
    Date of Event
    June 3, 2018
    Report Date
    January 2, 2019
    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

    AVERAGE AGE. MAJORITY GENDER. DATE OF PUBLICATION. CORONARY ARTERY CALCIUM SCORE IN PREDICTING PERIPROCEDURAL MYOCARDIAL INFARCTION IN PATIENTS UNDERGOING AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION. DOI: 10.1097/MCA.0000000000000651. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY AIMED TO EVALUATE WHETHER THE CORONARY ARTERY CALCIUM SCORE (CACS) MEASURED WITH COMPUTED TOMOGRAPHY CORONARY ANGIOGRAPHY (CTCA) PREDICTS PERIPROCEDURAL MYOCARDIAL INFARCTION (PMI) IN PATIENTS UNDERGOING AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION. 197 PATIENTS TREATED WITH OPTIMAL PCI WERE INCLUDED IN THIS STUDY. MEDTRONIC ZOTAROLIMUS DES WERE AMONG DES IMPLANTED. CLINICAL ADVERSE EVENTS IDENTIFIED WERE DEATH, REVASCULARIZATION (TLR, TVR), NON FATAL MYOCARDIAL INFARCTION, STROKE AND GASTROINTESTINAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death