BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 22196083 · Received June 12, 2025

    Report

    Report Number
    9612164-2025-02897
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    November 29, 2024
    Report Date
    June 19, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CORRECTION ANNEX E CODE FROM ANEURYSM E0501 TO E050102 ANEURYSM EXPANSION 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.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿THE LONG-TERM PROGRESSION OF ANEURYSMAL DISEASE IN COMMON ILIAC ARTERIES AFTER STANDARD EVAR AND ITS CLINICAL IMPLICATIONS¿ PITOULIAS AG, CHATZELAS D, PITOULIAS MG, POLITI LA, CHRISTOPOULOS DC, LAZARIDIS I, SARATZIS N, PITOULIAS GA INTERNATIONAL JOURNAL OF VASCULAR MEDICINE 2024 NOV 29;2024:4229582. DOI: 10.1155/IJVM/4229582. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ¿ THE LONG-TERM PROGRESSION OF ANEURYSMAL DISEASE IN COMMON ILIAC ARTERIES AFTER STANDARD EVAR AND ITS CLINICAL IMPLICATIONS¿ THE TIME FRAME OF THIS STUDY WAS OVER A FIVE YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. ENDURANT II STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. THE PURPOSE OF THIS STUDY IS TO INVESTIGATE THE LONG-TERM OUTCOMES OF STANDARD ELECTIVE EVAR WITH A VARIETY OF LAST-GENERATION BIFURCATED AORTIC ENDOGRAFTS IN RELATION WITH THE PROGRESSION OF ANEURYSMAL DISEASE IN THE CIAS. THE FOLLOWING ADVERSE EVENTS OCCURRED: RUPTURE, OCCLUSION , CLAUDICATION, ANEURYSM ENLARGEMENT, INTERVENTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779312 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention