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US Food & Drug Administration. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-corporation-recalls-vici-venous-stent-system-and-vici-rds-venous-stent-system [accessed 5 February 2022].
US Food & Drug Administration. Class 2 Device Recall VENOVO Venous Stent System, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=187686 [accessed 5 February 2022].
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US Food & Drug Administration. MAUDE - Manufacturer and User Facility Device Experience, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm [accessed 19 August 2021].
US Food & Drug Administration. Medical Device Reporting (MDR): How to Report Medical Device Problems, https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#requirements [accessed 5 February 2022].
US Food & Drug Administration. Statement on agency’s efforts to increase transparency in medical device reporting. https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting [5 February 2022].
- Venous Stents: Current Status and Future Directions.Tech Vasc Interv Radiol. 2018 Jun; 21: 113-116https://doi.org/10.1053/j.tvir.2018.03.007
- Physical Properties of Venous Stents: An Experimental Comparison.Cardiovasc Intervent Radiol. 2018 Jun; 41: 942-950https://doi.org/10.1007/s00270-018-1916-1
- A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files.EGEMS (Wash DC). 2017 Jun 14; 5: 12https://doi.org/10.5334/egems.221
- Barriers to Reporting: Limitations of the Maude Database.Dermatol Surg. 2021; 47: 424-425https://doi.org/10.1097/DSS.0000000000002832
- Product Recall Decisions in Medical Device Supply Chains: A Big Data Analytic Approach to Evaluating Judgment Bias.Prod Oper Manag. 2017; 27: 1670-1684https://doi.org/10.1111/poms.12696
- A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database.J Vasc Surg. 2021 Nov; 74: 1708-1720.e5https://doi.org/10.1016/j.jvs.2021.01.050
Government Accountability Office. GAO-12-816 Information Security of Active Medical Devices, https://www.gao.gov/assets/gao-12-816.pdf [accessed 5 February 2022].
US Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard, https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard [accessed 5 February 2022].
Publication stageIn Press Journal Pre-Proof
Presentation: Vascular and Endovascular Surgery Society (VESS) Winter 2022 Meeting; January 27-30, 2022; Snowmass, CO.