BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 8292306 · Received January 31, 2019

    Report

    Report Number
    2953200-2019-00186
    Event Type
    Death
    Date Received
    January 31, 2019
    Date of Event
    June 11, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: CURRENT EVIDENCE ON MANAGEMENT OF AORTIC STENT-GRAFT INFECTION: A SYSTEMATIC REVIEW AND META-ANALYSIS. HAI LEI LI, YIU CHE CHAN AND STEPHEN W. CHENG. ANN VASC SURG 2018; 51: 306¿313 HTTPS://DOI.ORG/10.1016/J.AVSG.2018.02.038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ANEURX, TALENT, ENDURANT AND UNKNOWN MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THORACIC AND AORTIC ENDOVASCULAR REPAIR. THE FOLLOWING EVENTS WERE REPORTED: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84552 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death