BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 20630974 · Received November 7, 2024

    Report

    Report Number
    9612164-2024-05150
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    April 26, 2024
    Report Date
    November 7, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; "PREEMPTIVE TREATMENT IN THE ACUTE AND EARLY SUBACUTE PHASE OF UNCOMPLICATED TYPE B AORTIC DISSECTIONS WITH POOR PROGNOSIS FACTORS"  SACHS C, VECCHINI F, CORNIQUET M, BARTOLI M, BARRALP - A, DE MASI M, OMNES V, PIQUET P, ALSAC J -M, GAUDRY M  FRONTIERS IN  CARDIOVASCULAR MEDICINE . 2024 APR 26;11:1362576.  DOI: 10.3389/FCVM.2024.1362576. 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 "PRE- EMPTIVE TREATMENT IN THE ACUTE AND EARLY SUBACUTE PHASE OF UNCOMPLICATED TYPE B AORTIC DISSECTIONS WITH POOR PROGNOSIS FACTORS".  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN TWO PATIENTS THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTION ON UNKNOWN DATES OVER A 10 YEAR PERIOD. THIS PATIENT POPULATION ALSO RECEIVED MEDICAL TREATMENT.  NON MDT STENT GRAFTS WERE ALSO IMPLANTED. AMONG THE PATIENT POPULATION, THE FOLLOWING ADVERSE EVENTS OCCURRED; LOWER LIMB ISCHEMIA, TYPE A DISSECTION, BLOOD LOSS, ACUTE RENAL FAILURE, TRANSIENT PARAPLEGIA, ANEURYSM , RENAL MALPERFUSION, RE-INTERVENTION  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611618 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention