BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 22950160 · Received September 3, 2025

    Report

    Report Number
    9612164-2025-04336
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 26, 2024
    Report Date
    September 3, 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; ¿SCORING SYSTEM TO PREDICT MID-TERM ADVERSE EVENTS AFTER ELECTIVE THORACIC ENDOVASCULAR AORTIC REPAIR¿ OUCHI T, KATO N, KATO H, HIGASHIGAWA T, ITO H, NAKAJIMA K, TOKUI T, OUE K, MIZUMOTO T, SAKUMA H. THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY. 2025 AUG;170(2):437-444.E11. DOI: 10.1016/J.JTCVS.2024.08.034 A.2 MEDIAN A.3 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 ¿SCORING SYSTEM TO PREDICT MID-TERM ADVERSE EVENTS AFTER ELECTIVE THORACIC ENDOVASCULAR AORTIC REPAIR¿ THE TIME FRAME OF THIS STUDY WAS OVER A THIRTEEN YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED INCLUDING MEDTRONIC VALIANT CAPTIVIA TALENT AS WELL AS NON-MDT STENT GRAFTS. THESE STENT GRAFTS WERE IMPLANTED IN ELECTIVE TEVAR PROCEDURES FOR INTACT THORACIC AORTIC ANEURYSMS OR AORTIC DISSECTIONS. THE FOLLOWING ADVERSE EVENTS OCCURRED: INTIMAL DISSECTION, OCCLUSION, PNEUMONIA, PULMONARY EMBOLISM, RUPTURE, INFECTION, ISCHEMIA, CEREBRAL INFARCTION, HEMATOMA, AORTIC DILATION, INTERVENTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734711 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| R