Edwards, Nicholas2025-06-032025-06-03https://hdl.handle.net/2097/45107Kirmser Undergraduate Research Award - Individual Non-Freshman category, grand prizeSubmitted to the Senior Vice and President and President of Boston Scientific's Interventional Cardiology Therapies division, this report explores the product failure of the VICI VENOUS STENT System from the perspective of a device development engineer. Key sections include reasons for design failure, the benefits and drawbacks associated with a product recall, as well as identified solutions through a new R&D interdisciplinary team to support Boston Scientific's mission in transforming lives through innovative solutions. Through countless submission in English 415, this Formal Report showcases the final exploration into the FDA's Device Development Process, which I will be directly entering in my new role after Graduation.VICI Venous Stent SystemBoston ScientificFood and Drug Administration Device Development ProcessInnovative Healthcare TransformationDevice Development EngineeringTextEdwards, N. (2024). A formal report exploring the addition of endoscopic suturing as an anti-migration feature for Boston Scientific's VICI Venous Stent System. Unpublished manuscript, Kansas State University, Manhattan, KS.