BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 23120468 · Received September 23, 2025

    Report

    Report Number
    9612164-2025-04700
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    April 11, 2023
    Report Date
    September 23, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿COMPUTATIONAL FLUID DYNAMICS ANALYSIS OF A NEW DISSECTION SPECIFIC STENT GRAFT WITH THE AIM TO PREVENT DISTAL STENT GRAFT INDUCED NEW ENTRY (DSINE)¿ YOON WJ, MANI K, WANHAINEN A. EUR J VASC ENDOVASC SURG (2023) 66, 146E147 DOI: 10.1016/J.EJVS.2023.04.004 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 ¿ COMPUTATIONAL FLUID DYNAMICS ANALYSIS OF A NEW DISSECTION SPECIFIC STENT GRAFT WITH THE AIM TO PREVENT DISTAL STENT GRAFT INDUCED NEW ENTRY (DSINE)¿ THE TIME FRAME OF THIS STUDY WAS OVER A THREE-YEAR PERIOD. VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF CHRONIC TYPE B AORTIC DISSECTIONS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS OCCURRED: DISTAL STENT GRAFT INDUCED NEW ENTRY (DSINE) NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579967 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other