BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7467763 · Received April 27, 2018

    Report

    Report Number
    9612164-2018-00926
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    December 19, 2017
    Report Date
    April 27, 2018
    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 NAME: CIRCULATION JOURNAL AUTHORS: MASANOBU OHYA, MD; TAKESHI MORIMOTO, MD, PHD; SHUNSUKE KUBO, MD; SEIJI HABARA, MD; AKIMUNE KUWAYAMA, MD; KATSUYA MIURA, MD ET AL. TITLE OF ARTICLE: TWO-YEAR OUTCOMES AND PREDICTORS OF TARGET LESION REVASCULARIZATION FOR NON-LEFT MAIN CORONARY BIFURCATION LESIONS FOLLOWING TWO-STENT STRATEGY WITH 2ND-GENERATION DRUG-ELUTING STENTS LITERATURE REFERENCE: DOI: 10.1253/CIRCJ.CJ-17-1092 YEAR: 2018 ISSUE #: 82. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING PROCEDURES, THE FOLLOWING BIFURCATIONS WERE TREATED - LAD/DIAGONAL, RCA/BRANCH AND LCX/OBTUSE MARGINAL. THE FOLLOWING EVENTS WERE REPORTED IN THE 1-YEAR AND 2-YEAR FOLLOW-UPS; TARGET LESION REVASCULARIZATION, DEATH, MYOCARDIAL INFARCTION AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310525 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other