BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10559285 · Received September 21, 2020

    Report

    Report Number
    9612164-2020-03526
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 21, 2020
    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 OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: BELL-BOTTOM TECHNIQUE IN ILIAC BRANCH ERA: MID-TERM SINGLE STENT GRAFT PERFORMANCE. PAGLIARICCIO, G., GATTA, E., SCHIAVON, S. ET AL. BELL-BOTTOM TECHNIQUE IN ILIAC BRANCH ERA: MID-TERM SINGLE STENT GRAFT PERFORMANCE. CVIR ENDOVASC 3, 57 (2020). HTTPS://DOI.ORG/10.1186/S42155-020-00147-W. PATIENT AGE: AVERAGE PATIENT AGE. GENDER: MEAN GENDER. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS RECEIVING STANDARD EVAR COMBINED WITH BELLBOTTOM TECHNIQUE (BBT). THE FOLLOWING ADVERSE EVENTS WERE REPORTED: ILIAC OCCLUSION, ANEURYSM EXPANSION, IIA ANEURYSM, ADJUNCTIVE PROCEDURES, FEMORO-FEMOROL BYPASS AND ILIAC OBSTRUCTION. THE CAUSES OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027925 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention