BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 22284283 · Received June 18, 2025

    Report

    Report Number
    9612164-2025-03014
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    October 25, 2024
    Report Date
    June 18, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿ EFFECT OF AORTIC THROMBUS ON OUTCOMES FOLLOWING REPAIR OF JUXTARENAL ANEURYSMS USING PHYSICIAN MODIFIED ENDOGRAFTS¿ NELSON C, ANDERSON G, LARIMORE A, DANSEY KD, STARNES BW, ZETTERVALL SL. EUROPEAN JOURNAL OF VASCULAR ENDOVASCULAR SURGERY (2025) 69, 568E575 DOI: 10.1016/J.EJVS.2024.10.035. A.2 <(>&<)> A.3A AVERAGE MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ¿EFFECT OF AORTIC THROMBUS ON OUTCOMES FOLLOWING REPAIR OF JUXTARENAL ANEURYSMS USING PHYSICIAN MODIFIED ENDOGRAFTS¿ THE TIME FRAME OF THIS STUDY WAS OVER A TWELVE YEAR PERIOD. ENDURANT II AND NON MDT STENT GRAFTS WERE PHYSICIAN MODIFIED AND IMPLANTED IN THE ENDOVASCULAR TREATMENT OF JUXTARENAL ABDOMINAL AORTIC ANEURYSMS. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: IA ENDOLEAK, TYPE IB ENDOLEAK, TYPE III ENDOLEAK , MIGRATION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788576 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male