ANALYSIS OF ADVERSE EVENTS ASSOCIATED WITH RENAL STENTS: A REVIEW OF THE MAUDE DATABASE

Kakani Subhash, Ajoshson John, Deeksha S., Pramod Kumar A., Michelle Jaslyn Lewis, M. Kruthika, Sannidhi Prabhu, Jeesa George*

ABSTRACT

Background: The present study was conducted to determine the adverse events (AEs) associated with renal stents reported to the Food and Drug Administration manufacturer and user facility device experience (MAUDE) database. Materials and methods: The authors reviewed the renal stents related AEs reported to MAUDE from Jan 1, 2014, to Oct 30, 2024. Analyses of details collected are presented. Results: The MAUDE database reported 604 AEs related to renal stents. Of these, 79 were classified as "Adverse Event without Identified Device or Use Problem," and 68 involved "Device Dislodged or Dislocated." The highest incidence occurred in the 65-79 age group (47%), followed by 50-64 (20.9%) and 80+ (20%). More events were reported in females than males. Common patient issues included "No Consequences or Impact" (191) and "No Clinical Signs or Symptoms" (124). The U.S. reported the most events (207), followed by Switzerland (47). Outcomes showed 286 events required intervention, with 218 evaluated by the manufacturer, and most events were due to device malfunction (263) and injury (319). Conclusion: Renal stents pose risks to patient safety if not properly managed. MAUDE data highlights AEs, underscoring the need for further analysis. Until more studies emerge, operators must exercise caution, follow best practices, and raise awareness to enhance patient education and support informed decision-making during procedures.

Keywords: MAUDE, Adverse events, renal stents.