BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7991371 · Received October 22, 2018

    Report

    Report Number
    9612164-2018-02863
    Event Type
    Death
    Date Received
    October 22, 2018
    Date of Event
    October 23, 2017
    Report Date
    October 22, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: CLINICAL OUTCOMES OF COMPLEX REAL-WORLD DIABETIC PATIENTS TREATED WITH AMPHILIMUS SIROLIMUS-ELUTING STENTS OR ZOTAROLIMUS-ELUTING STENTS: A SINGLE-CENTER REGISTRY RIK ROZEMEIJER A, DANIELA BENEDETTO A, ADRIAAN O. KRAAIJEVELD A, MICHIEL VOSKUIL A, MÈRA STEIN A, LEO TIMMERS A, SASKIA Z. RITTERSMA A, PIERFRANCESCO AGOSTONI A,B, PIETER A. DOEVENDANS A,C, PIETER R. STELLA CARDIOVASCULAR REVASCULARIZATION MEDICINE 19 (2018) 521¿525 HTTPS://DOI.ORG/10.1016/J.CARREV.2017.10.011 1553-8389/© 2017 ELSEVIER INC. ALL RIGHTS RESERVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT HAD AN RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE RCA, HOWEVER, THE PATIENT DIED 20 DAYS POST INDEX FROM AN UNEXPLAINED CARDIAC DEATH. DEGREE OF CERTAINTY OF STENT THROMBOSIS WAS DEEMED PROBABLE. PATIENT WAS ON ASPIRIN AND CLOPIDOGREL AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833536 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death