BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4133436 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01959
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6 CM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON DURING THE TEVAR PROCEDURE, THE VALIANT STENT GRAFT WAS INACCURATELY DELIVERED COVERING THE LEFT CAROTID ARTERY. THE CAUSE OF THE EVENT WAS DUE TO A PREVIOUS TAG GRAFT THAT WAS IN PLACE ALONG WITH AN ELEPHANT TRUNK. DUE TO THE POOR POSITION OF THE GORE GRAFT, THE VALIANT STENT GRAFT GOT STUCK AGAINST THE GORE. THE PHYSICIAN THEN SNORKELED THE CAROTID ARTERY WITH A 9MM ATRIUM STENT SUCCESSFULLY RESTORING FLOW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM REVIEW ANALYSIS: REVIEW OF SEVERAL STILL ANGIO IMAGES CONFIRMED THAT GORE STENT GRAFT WAS IMPLANTED JUST DISTAL TO THE LSA NEAR THE END OF THE ARCH. THE PROXIMAL END OF THE GORE STENT GRAFT IS PERPENDICULAR TO THE ARCH. A VALIANT STENT GRAFT IS SEEN PARTIALLY DEPLOYED PROXIMAL TO THE GORE. THE BARE SPRING IS RETAINED WITHIN THE TIP. POST-DEPLOYMENT IMAGES WERE NOT RETURNED. THE CAUSE OF THE INACCURATE DELIVERY APPEARS LIKELY RELATED TO THE POOR POSITION OF THE GORE DEVICE WITHIN THE ANGULATED ARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612460 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04665278

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention