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Case report of an endovascular repair of a residual type A dissection using a not CE not FDA-approved Najuta thoracic stent graft system


Mangialardi, N; Ronchey, S; Malaj, A; Lachat, M; Serrao, E; Alberti, V; Fazzini, S (2015). Case report of an endovascular repair of a residual type A dissection using a not CE not FDA-approved Najuta thoracic stent graft system. Medicine, 94(3):e436.

Abstract

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).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. We used the Najuta thoracic stent graft and successfully handled the pathology in a multiple-phase treatment.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.

Abstract

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).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. We used the Najuta thoracic stent graft and successfully handled the pathology in a multiple-phase treatment.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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:German
Date:January 2015
Deposited On:02 Feb 2016 13:12
Last Modified:03 Aug 2017 17:25
Publisher:Lippincott Williams & Wilkins
ISSN:0025-7974
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1097/MD.0000000000000436
PubMed ID:25621698

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