BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7349040 · Received March 19, 2018

    Report

    Report Number
    2953200-2018-00382
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    September 24, 2017
    Report Date
    March 19, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; EVALUATION OF DELAYED ENDOLEAK COMPARED WITH EARLY ENDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR TRONG BINH LE, MD, KEUN-MYOUNG PARK, MD, YONG SUN JEON, MD, PHD, KEE CHUN HONG, MD, PHD, AND SOON GU CHO, MD, PHD HTTPS://DOI.ORG/10.1016/J.JVIR.2017.09.023. AVERAGE AGE, AVERAGE GENDER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS WERE USED IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. ADVERSE EVENTS NOTED; ANEURYSM RUPTURE, REINTERVENTION, ANEURYSM ENLARGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192160 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention