BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 24108367 · Received January 19, 2026

    Report

    Report Number
    9612164-2026-00333
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    September 11, 2025
    Report Date
    January 19, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; LONG-TERM OUTCOMES AND RISK FACTORS AFTER HYBRID THORACIC ENDOVASCULAR AORTIC REPAIR WITH LANDING IN ZONES 1 AND 2 KUDO T, KURATANI T, SAKAMOTO T, YOKOTA J, OGA Y <(>&<)> SAWA Y ANN VASC SURG 2026; 122: 574¿585 HTTPS://DOI.ORG/10.1016/J.AVSG.2025.08.043. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 ¿LONG-TERM OUTCOMES AND RISK FACTORS AFTER HYBRID THORACIC ENDOVASCULAR AORTIC REPAIR WITH LANDING IN ZONES 1 AND 2¿ THE TIME FRAME OF THIS STUDY WAS OVER A TEN-YEAR PERIOD. 96 PATIENTS UNDERWENT ZONES 1 AND 2 LANDING HYBRID TEVAR FOR AORTIC ARCH PA THOLOGIES. VALIANT AND NON-MEDTRONIC STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: TYPE IA ENDOLEAK, TYPE III ENDOLEAK NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170318 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male