BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX - UNK

    MDR report key: 22435741 · Received July 8, 2025

    Report

    Report Number
    9612164-2025-03349
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 8, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿HIGHER ALL-CAUSE BUT NOT AORTIC-RELATED MORTALITY FOR WOMEN AFTER ABDOMINAL AORTIC ANEURYSM REPAIR¿ CLAUDIO MEDINA Y, FARRES H, ARROYO HM, POLANIA SANDOVAL C, JACOBS C, VERNON CE, VANDENBERG J, ERBEN Y JOURNAL OF SURGICAL RESEARCH. 2025 JUL;311:172-180. DOI: 10.1016/J.JSS.2025.04.030. SECTION A 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 ¿ HIGHER ALL-CAUSE BUT NOT AORTIC-RELATED MORTALITY FOR WOMEN AFTER ABDOMINAL AORTIC ANEURYSM REP AIR¿ THE TIME FRAME OF THIS STUDY WAS OVER A TEN YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. MEDTRONIC ANEURX, ENDURANT II AND NON MDTSTENT GRAFTS WERE IMPLANTED IN EVAR PROCEDURES. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: IA ENDOLEAK, IB ENDOLEAK NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378230 ANEURX - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ANEURX

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male