BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 22368399 · Received July 1, 2025

    Report

    Report Number
    9612164-2025-03224
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    January 16, 2023
    Report Date
    July 1, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿A STATISTICAL SHAPE MODEL OF INFRARENAL AORTIC NECKS IN PATIENTS WITH AND WITHOUT LATE TYPE IA ENDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR¿ VAN VELDHUIZEN WA, SCHUURMANN RCL, ZUIDEMAR, GERAEDTS ACM, IJPMA FFA, KROPMAN RHJ, ANTONIOU GA, VAN SAMBEEK MRHM, BALM R, WOLTERINK JM, DE VRIES JPM J ENDOVASC THER. 2024 OCT;31(5):882-891. DOI: 10.1177/15266028221149913. 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 ¿A STATISTICAL SHAPE MODEL OF INFRARENAL AORTIC NECKS IN PATIENTS WITH AND WITHOUT LATE TYPE IA E NDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR¿ THE TIME FRAME OF THIS STUDY WAS OVER A TWELVE-YEAR PERIOD. TALENT, ENDURANT AND NON-MDT STENT GRAFTS WERE IMPLANTED IN EVAR PROCEDURES ON UNKNOWN DATES. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: TYPE IA ENDOLEAKS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206886 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