BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4111760 · Received September 23, 2014

    Report

    Report Number
    2953200-2014-01904
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 6.4 IN DIAMETER THORACIC AORTIC ANEURYSM. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. A RECENT CT REVEALED THAT THERE IS A DISTAL TYPE 1B ENDOLEAK AND THE GROWTH OF ANOTHER TAA DISTAL TO GRAFT, CONTINUED DISEASE PROGRESSION. ANEURYSM THAT DEVELOPED DISTAL TO INITIAL GRAFT WAS COVERED BY IMPLANTING A VALIANT 32X32X150 PROXIMAL MAIN PROXIMAL TO CELIAC ARTERY AND EXTENDING INTO THE PREVIOUSLY PLACED STENT GRAFTS. THE REPAIR WAS DONE DISTAL TO PROXIMAL. THE PHYSICIAN IMPLANTED A VALIANT 34X34X150 PROXIMAL MAIN PROXIMALLY AND UP TO THE LEVEL OF THE AORTIC ARCH, ABOUT 4CM DISTAL TO THE LSA. BOTH DEVICES DELIVERED AND REMOVED WITHOUT ISSUE AND FINAL ANGIOGRAM REVEALED SEAL OF THE TAA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE EXACT DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592190 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04171542

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention