BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 8389567 · Received March 5, 2019

    Report

    Report Number
    2953200-2019-00313
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    August 17, 2018
    Report Date
    March 5, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; LATE OPEN CONVERSIONS AFTER ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR IN AN URGENT SETTING. PAOLO PERINI, MAURO GARGIULO, ROBERTO SILINGARDI, ELIO PICCININI, PATRIZIO CAPELLI, ANTONIO FONTANA, MATTIA MIGLIARI, GIANCARLO MASI, MATTEO SCABINI, NICOLA TUSINI, GIANLUCA FAGGIOLI, AND ANTONIO FREYRIE. J VASC SURG 2019 (69) ISSUE 2 HTTPS://DOI.ORG/10.1016/J.JVS.2018.04.055. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT, TALENT AND ANUERX STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR ENDOVASCULAR ANEURYSM REPAIR. THE PATIENTS REQUIRED LATE OPEN CONVERSION. THE FOLLOWING EVENTS WERE REPORTED: SERIOUS INJURY- RUPTURE, INFECTION, ABDOMINAL PAIN, BACK PAIN, SEPSIS, HAEMORRHAGIC SHOCK, THROMBOSIS, EXPLANT, AORTOENTERIC FISTULA, INTERVENTION FOR ENDOLEAKS, OCCLUSION, THROMBUS, MI, MULTIPLE ORGAN FAILURE, HYPOTENSION, RENAL FAILURE, ISCHEMIA, PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182479 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention