Case Report of an Endovascular Repair of a Residual Type A Dissection Using a Not CE Not FDA-Approved Najuta Thoracic Stent Graft System. Issue 3 (January 2015)

• Record Type: Journal Article
• Authors: Mangialardi, N.; Ronchey, S.; Malaj, A.; Lachat, M.; Serrao, E.; Alberti, V.; Fazzini, S.; Leischik., Roman
• Is Part Of: Medicine. Volume 94:Issue 3(2015)
• Publication Date: 2015-01
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Médecine -- Périodiques; Geneeskunde; Medicine; Periodicals; Periodicals; 610.5
• DOI: 10.1097/MD.0000000000000436
• Languages: English
• ISSNs: 0025-7974

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Abstract</title> <p>This report describes an endovascular repair of a residual type A dissection using a medical device that is not marked by european conformity (CE) or Food and Drug Administration (FDA).</p> <p>The patient underwent ascending aortic surgery for acute type A dissection. The 2-year angio–computed tomography demonstrated patency of the residual false lumen with evolution into a 6 cm aneurysm, the extension of the dissection from the aortic arch to the aortic bifurcation with thrombosis of the right common iliac artery. There was no CE- or FDA-marked medical device indicated for this case or any other acceptable therapeutic alternative.</p> <p>We used the Najuta thoracic stent graft and successfully handled the pathology in a multiple-phase treatment.</p> <p>Technology is evolving with specific grafts for the ascending and fenestrated grafts for the aortic arch. In this single case the Najuta endograft, in spite of the periprocedural problems, was a valid therapeutic option.</p> </sec> </abstract>