BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8644235 · Received May 27, 2019

    Report

    Report Number
    9612164-2019-01994
    Event Type
    Death
    Date Received
    May 27, 2019
    Date of Event
    January 29, 2019
    Report Date
    May 27, 2019
    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 ARTICLE: PERIPROCEDURAL AND LONG-TERM OUTCOMES OF STENT IMPLANTATION FOR DE NOVO SUBCLAVIAN ARTERY DISEASE DOI: 10.1177/1538574418824444. AVERAGE AGE, MAJORITY GENDER, DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PURPOSE OF THE CURRENT STUDY WAS TO INVESTIGATE THE PERIPROCEDURAL AND LONG-TERM OUTCOMES OF STENT IMPLANTATION FOR DE NOVO SUBCLAVIAN ARTERY (SCA) DISEASE. PATIENTS WITH DE NOVO SCA LESIONS WHO UNDERWENT EVT PROCEDURES WERE INCLUDED IN THE ANALYSES OF PERIPROCEDURAL OUTCOMES. ASSURANT COBALT STENTS, DRIVER BARE METAL STENTS AND RESOLUTE INTEGRITY DRUG ELUTING STENTS WERE AMONG THE STENTS IMPLANTED. CLINICAL OUTCOMES REPORTED INCLUDED STENOSIS, RESTENOSIS, OCCLUSION, RE INTERVENTION OF THE TARGET VESSEL, DISTAL EMBOLISM, DISSECTION, PSEUDOANEURYSM AT ACCESS SITES, HEMATOMA AT ACCESS SITES, DEATH AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436704 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death