BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6943403 · Received October 12, 2017

    Report

    Report Number
    9612164-2017-01451
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUTHOR: KALKMAN, DEBORAH N; KALKMAN, DEBORAH N; KOK, MARLIES M; VAN DER HEIJDEN, LIEFKE C; WOUDSTRA, PIER; BEIJK, MARCEL AM; TIJSSEN, JAN GP; VON BIRGELEN, CLEMENS; DE WINTER, ROBBERT J; NLM JOURNAL: EUROINTERVENTION YEAR: 2017 ISSUE: SEPTEMBER 2017 TITLE: CLINICAL OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION WITH THE COMBO STENT VERSUS RESOLUTE INTEGRITY AND PROMUS ELEMENT STENTS: A PROPENSITY-MATCHED ANALYSIS. REF: DOI: 10.4244/EIJ-D-17-00301.

    Description of Event or Problem · 1

    A PROPENSITY SCORE MATCHED ANALYSIS WAS PERFORMED WITH DATA FROM THE REMEDEE REGISTRY (PATIENTS TREATED WITH A NON-MDT STENT) AND DUTCH PEERS TRIAL (NON-MDT STENT AND MEDTRONIC RESOLUTE INTEGRITY DRUG ELUTING STENTS). THE ANALYSIS FOUND SIMILAR SAFETY AND EFFICACY OUTCOMES FROM THE TWO STUDIES. PATIENT EVENT OUTCOMES INCLUDED CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, TARGET LESION REVASCULARISATION, STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723289 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention