Medical Devices: Evidence and Research (Nov 2019)
Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database
Abstract
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 [email protected]: 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
