BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 12352789 · Received August 23, 2021

    Report

    Report Number
    9612164-2021-03233
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    April 5, 2021
    Report Date
    August 23, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; THE INITIAL EXPERIENCE ON BRANCHED AND FENESTRATED ENDOGRAFTS IN THE AORTIC ARCH. A SYSTEMATIC REVIEW AMIL ET AL, ANN VASC SURG 2021; 75: 29¿44 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.03.024. MEAN AGE, MEAN GENDER, EXACT DATE OF IMPLANT UNKNOWN THERE WERE INTRAOPERATIVE AND POST OPERATIVE DEATHS REPORTED HOWEVER THERE WAS NO INFORMATION TO SUGGEST ANY OF THE DEATHS WERE IN THE PATIENTS WITH MEDTRONIC DEVICES. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED MDR REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT NAVION STENT GRAFT SYSTEMS WERE IMPLANTED IN CONJUNCTION WITH NON MDT STENT GRAFT SYSTEMS DURING FEVAR AND BEVAR IN PATIENTS WITH THORACIC AORTIC ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: VESSEL RUPTURE, SURGICAL CONVERSION, REINTERVENTION, STROKE, PARAPLEGIA, PNEUMONIA, OCCLUSIONS, GRAFT INFECTION, MOCARDIAL INFARCTION, ACUTE RENAL INSUFFICIENCY AND SEPSIS. THE CAUSE OF EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250961 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention