Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database

Neel A Mansukhani, Meraaj S Haleem, Mark K Eskandari Division of Vascular Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USACorrespondence: Mark K EskandariDivision of Vascular Surgery, 676 N St. Clair St., Suite 650, Chicago, IL 60611, USATel +1 312-926-7775Fax +1...

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Autores principales:	Mansukhani NA, Haleem MS, Eskandari MK
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	tevar food and drug administration maude complications Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/343411cf43b9463c91a55c565f734c4d
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spelling	oai:doaj.org-article:343411cf43b9463c91a55c565f734c4d2021-12-02T03:00:07ZThoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database1179-1470https://doaj.org/article/343411cf43b9463c91a55c565f734c4d2019-11-01T00:00:00Zhttps://www.dovepress.com/thoracic-endovascular-aortic-repair-adverse-events-reported-in-the-foo-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Neel A Mansukhani, Meraaj S Haleem, Mark K Eskandari Division of Vascular Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USACorrespondence: Mark K EskandariDivision of Vascular Surgery, 676 N St. Clair St., Suite 650, Chicago, IL 60611, USATel +1 312-926-7775Fax +1 312-695-4955Email meskanda@nm.orgPurpose: The purpose of this study is to identify adverse events (device- and patient-related) associated with thoracic aortic stent graft systems and their timing post-procedure.Materials and methods: The Food and Drug Administration’s Manufacturer and User Facility Device Experience (FDA-MAUDE) voluntary database was searched for Thoracic Aortic Endovascular Repair (TEVAR) devices reported over the course of 1 year (January 1, 2014 to December 31, 2014). The data abstracted included the indication for treatment, device used, and adverse events.Results: During 2014, there were 334 original submissions to the FDA-MAUDE database describing 371 adverse events regarding TEVAR devices that met inclusion criteria for this study. All submissions were from manufacturers, and none were from physicians. The most common pathologies treated were thoracic aortic aneurysm (67.6%) and type B aortic dissection (25.1%). The most frequently reported intraoperative, early postoperative (<30 days), and late postoperative (>30 days) events overall were technical device failure, neurologic complications (stroke, paraplegia), and endoleak, respectively. Of note, there were descriptions of retained deployment materials, late graft infections, and aorto-visceral fistula formation up to 3 years postoperatively.Conclusion: The MAUDE database is a valuable repository for complications and device failures that are not otherwise in the published literature and submitted by manufacturers relating to this relatively new technology.Keywords: TEVAR, Food and Drug Administration, MAUDE, complicationsMansukhani NAHaleem MSEskandari MKDove Medical Pressarticletevarfood and drug administrationmaudecomplicationsMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 12, Pp 461-467 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	tevar food and drug administration maude complications Medical technology R855-855.5
spellingShingle	tevar food and drug administration maude complications Medical technology R855-855.5 Mansukhani NA Haleem MS Eskandari MK Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
description	Neel A Mansukhani, Meraaj S Haleem, Mark K Eskandari Division of Vascular Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USACorrespondence: Mark K EskandariDivision of Vascular Surgery, 676 N St. Clair St., Suite 650, Chicago, IL 60611, USATel +1 312-926-7775Fax +1 312-695-4955Email meskanda@nm.orgPurpose: The purpose of this study is to identify adverse events (device- and patient-related) associated with thoracic aortic stent graft systems and their timing post-procedure.Materials and methods: The Food and Drug Administration’s Manufacturer and User Facility Device Experience (FDA-MAUDE) voluntary database was searched for Thoracic Aortic Endovascular Repair (TEVAR) devices reported over the course of 1 year (January 1, 2014 to December 31, 2014). The data abstracted included the indication for treatment, device used, and adverse events.Results: During 2014, there were 334 original submissions to the FDA-MAUDE database describing 371 adverse events regarding TEVAR devices that met inclusion criteria for this study. All submissions were from manufacturers, and none were from physicians. The most common pathologies treated were thoracic aortic aneurysm (67.6%) and type B aortic dissection (25.1%). The most frequently reported intraoperative, early postoperative (<30 days), and late postoperative (>30 days) events overall were technical device failure, neurologic complications (stroke, paraplegia), and endoleak, respectively. Of note, there were descriptions of retained deployment materials, late graft infections, and aorto-visceral fistula formation up to 3 years postoperatively.Conclusion: The MAUDE database is a valuable repository for complications and device failures that are not otherwise in the published literature and submitted by manufacturers relating to this relatively new technology.Keywords: TEVAR, Food and Drug Administration, MAUDE, complications
format	article
author	Mansukhani NA Haleem MS Eskandari MK
author_facet	Mansukhani NA Haleem MS Eskandari MK
author_sort	Mansukhani NA
title	Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
title_short	Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
title_full	Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
title_fullStr	Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
title_full_unstemmed	Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
title_sort	thoracic endovascular aortic repair adverse events reported in the food and drug administration manufacturer and user facility device experience database
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/343411cf43b9463c91a55c565f734c4d
work_keys_str_mv	AT mansukhanina thoracicendovascularaorticrepairadverseeventsreportedinthefoodanddrugadministrationmanufactureranduserfacilitydeviceexperiencedatabase AT haleemms thoracicendovascularaorticrepairadverseeventsreportedinthefoodanddrugadministrationmanufactureranduserfacilitydeviceexperiencedatabase AT eskandarimk thoracicendovascularaorticrepairadverseeventsreportedinthefoodanddrugadministrationmanufactureranduserfacilitydeviceexperiencedatabase
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Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database

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