BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 25080517 · Received May 5, 2026

    Report

    Report Number
    9612164-2026-02316
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    September 11, 2025
    Report Date
    May 5, 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 WERE INFORMED OF THE FOLLOWING LITERATURE ARTICLE; LONG-TERM OUTCOMES AND RISK FACTORS AFTER HYBRID THORACIC ENDOVASCULAR AORTIC REPAIR WITH LANDING IN ZONES 1 AND 2. TOMOAKI KUDO, TORU KURATANI, TOMOHIKO SAKAMOTO, JUNKI YOKOTA, YUKI OGA, AND YOSHIKI SAWA, OSAKA, OSAKA, JAPAN HTTPS://DOI.ORG/10.1016/J.AVSG.2025.08.043 A2: MEAN AGE A3B: MEAN GENDER EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    FROM APRIL 2014 TO MARCH 2024, 96 PATIENTS UNDERWENT ZONES 1 AND 2 LANDING HYBRID TEVAR FOR AORTIC ARCH PATHOLOGIES. THE PRIMARY ENDPOINT WAS MAJOR ADVERSE AORTA-RELATED EVENTS (LATE RUPTURE/DISSECTION AND/OR AORTA-RELATED REINTERVENTION). THE SECONDARY ENDPOINT WAS TYPE 1A ENDOLEAK. OUTCOMES WERE ANALYZED BY KAPLAN¿MEIER AND LOG-RANK TEST. THE TIME FRAME OF THIS STUDY WAS JANUARY 2020 TO APRIL 2024. 96 PATIENTS WERE INCLUDED IN THE COHORT. THE FOLLOWING MEDTRONIC DEVICES WERE USED: VALIANT CAPTIVIA STENT GRAFT. THE ADVERSE EVENT NOTED WERE MALFUNCTIONS; TYPE IA AND III ENDOLEAKS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290698 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1