BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT

    MDR report key: 4181119 · Received October 17, 2014

    Report

    Report Number
    2953200-2014-02106
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A DISTAL TYPE I ENDOLEAK. CURRENTLY THERE IS DISEASE PROGRESSION WITH VESSEL DILATATION. IT WAS REPORTED THAT THERE IS A DISTAL TYPE I ENDOLEAK PRESENT AND THE MOST DISTAL DEVICE APPEARS TO BE FLOATING WITHIN THE ENLARGED TAA. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE FILM REVIEW FROM ONE MONTH AGO REVEALED THAT THE MOST DISTAL DEVICE APPEARS TO BE FLOATING WITHIN THE ENLARGED TAA AND THERE IS A LIKELY DISTAL TYPE I ENDOLEAK. THE MAX DIAMETER TAA IS 8.7CM. THE TALENT CONVERTER IS NOW APPROXIMATELY 4.5CM BELOW THE RENALS, AND A VALIANT CUFF HAS BEEN IMPLANTED TO 1CM BELOW THE LEFT RENAL ARTERY; OVERLAPPING THE CONVERTER. THE MAX AAA DIAMETER IS 5.4CM. IMAGES IMMEDIATELY POST-IMPLANT WERE NOT PROVIDED, BUT IT IS LIKELY THAT THE CAUSE OF THE EVENTS WERE MOST LIKELY DUE TO DISEASE PROGRESSION AND MORPHOLOGY CHANGES. THE REPORTED TYPE III SEPARATION COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661728 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03996177

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR