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      A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems.

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          Abstract

          The first two Food and Drug Administration (FDA)-approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's Vici and BD's Venovo venous stent systems, were both recalled in early 2021 within years of entering the market. Given the recent addition of patient issues as a publicly reported variable by the FDA Manufacturer and User Facility Device Experience (MAUDE) database, we set forth to analyze adverse event reports in MAUDE to better characterize issues reported for each system.

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          Author and article information

          Journal
          Ann Vasc Surg
          Annals of vascular surgery
          Elsevier BV
          1615-5947
          0890-5096
          Nov 2022
          : 87
          Affiliations
          [1 ] Virginia Commonwealth University School of Medicine, Richmond, VA.
          [2 ] Virginia Commonwealth University School of Medicine, Richmond, VA; Central Virginia VA Health Care System, Richmond, VA; Virginia Commonwealth University Health System, Richmond, VA. Electronic address: kedar.lavingia@gmail.com.
          [3 ] Virginia Commonwealth University School of Medicine, Richmond, VA; Central Virginia VA Health Care System, Richmond, VA; Virginia Commonwealth University Health System, Richmond, VA.
          Article
          S0890-5096(22)00483-6
          10.1016/j.avsg.2022.08.002
          36055459
          56c8a08b-7f3a-4736-8864-ad0ee7618ec9
          History

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