BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 22506490 · Received July 15, 2025

    Report

    Report Number
    9612164-2025-03457
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    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; ¿ASSOCIATION BETWEEN GERIATRIC NUTRITIONAL RISK INDEX AND DISCHARGE OUTCOME AFTER ELECTIVE THORACIC ENDOVASCULAR AORTIC REPAIR¿ OUCHI T, KATO N, KATO H, HIGASHIGAWA T, ITO H, NAKAJIMA K, CHINO S, TOKUI T, OUE K, MIZUMOTO T, ICHIKAWA Y, SAKUMA H. CARDIOVASC INTERVENT RADIOL. 2025 JUN;48(6):807-814. DOI: 10.1007/S00270-025-04066-Y 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 ¿ASSOCIATION BETWEEN GERIATRIC NUTRITIONAL RISK INDEX AND DISCHARGE OUTCOME AFTER ELECTIVE THORACIC ENDOVASCULAR AORTIC REPAIR¿ THE TIME FRAME OF THIS STUDY WAS OVER A THIRTEEN-YEAR PERIOD. MEDTRONIC TALENT, VALIANT CAPTIVIA, VALIANT NAVION AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. 229 PATIENTS UNDERGOING ELECTIVE SIMPLE TEVAR FOR INTACT TAA OR SUBACUTE OR CHRONIC AD AND NOT EXPERIENCING NEUROLOGICAL COMPLICATIONS OR RE-INTERVENTIONS DURING HOSPITALIZATION WERE INCLUDED IN THE STUDY POPULATION. THE FOLLOWING ADVERSE EVENTS OCCURRED: INFECTION, FEVER, HEART FAILURE, NEUROLOGICAL COMPLICATIONS, INTERVENTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771619 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention