BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13011178 · Received December 15, 2021

    Report

    Report Number
    9612164-2021-04875
    Event Type
    Death
    Date Received
    December 15, 2021
    Date of Event
    April 24, 2021
    Report Date
    December 15, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; IMPACT OF INSTRUCTIONS FOR USE AND ENDOLEAKS ON LONG-TERM MORTALITY AFTER TREATMENT FOR ABDOMINAL AORTIC ANEURYSM HIROSHI SATO, JOJI FUKADA, AND YUKIHIKO TAMIYA, ANNALS OF VASCULAR SURGERY; ANN VASC SURG 2021; 76: 309¿317 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.03.047 A2: MEAN AGE A3: MEAN GENDER D6A: EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT STENT GRAFTS WERE IMPLANTED DURING OPEN AND EVAR OF AAA ON UNKNOWN DATES. SOME PATIENTS WERE TREATED OUTSIDE THE IFU. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: DEATH. THE CAUSE OF THE DEATHS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905851 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| D