Adverse Events Linked to Renal Stents : A Review of the MAUDE Database
Author(s)
Ajoshson John, PharmD1, Deeksha S, PharmD2, Adusumilli Pramod Kumar, Ph.D3, JEESA GEORGE, M Pharm3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
OBJECTIVES: Renal artery stents are used to manage arterial stenosis contributing to resistant hypertension, ischemic nephropathy, and cardiovascular complications. Despite their therapeutic benefits, renal stents may be associated with adverse events. This study aims to analyze reported complications related to renal stents using the MAUDE (Manufacturer and User Facility Device Experience) database, focusing on patient demographics, event types, and clinical outcomes.
METHODS: A retrospective review was conducted using MAUDE database entries from January 1, 2014, to October 30, 2024. Reports referencing renal stents were extracted and categorized by device problem, patient outcome, age group, sex, and country of origin. Descriptive statistical methods were used to summarize and evaluate reporting patterns.
RESULTS: A total of 604 adverse event reports involving renal stents were identified. The most frequently cited device issues were “Adverse Event Without Identified Device or Use Problem” (79/604) and “Device Dislodged or Dislocated” (68/604). The highest incidence was among patients aged 65-79 years (47%), followed by 50-64 years (20.9%) and 80+ years (20%). Female patients accounted for a greater proportion of reports than males. Common outcomes included “No Consequences or Impact” (191/604) and “No Clinical Signs or Symptoms” (124/604). The majority of reports originated from the United States (207), followed by Switzerland (47). Medical intervention was required in 286 cases. Of all reports, 263 described device malfunctions, and 319 reported patient injury.
CONCLUSIONS: Adverse events related to renal stents are more frequently reported in older adults, with device malfunctions and injuries comprising a significant portion of cases. These findings underscore the importance of continuous post-market surveillance, operator training, and patient counseling to mitigate risk and improve outcomes.
METHODS: A retrospective review was conducted using MAUDE database entries from January 1, 2014, to October 30, 2024. Reports referencing renal stents were extracted and categorized by device problem, patient outcome, age group, sex, and country of origin. Descriptive statistical methods were used to summarize and evaluate reporting patterns.
RESULTS: A total of 604 adverse event reports involving renal stents were identified. The most frequently cited device issues were “Adverse Event Without Identified Device or Use Problem” (79/604) and “Device Dislodged or Dislocated” (68/604). The highest incidence was among patients aged 65-79 years (47%), followed by 50-64 years (20.9%) and 80+ years (20%). Female patients accounted for a greater proportion of reports than males. Common outcomes included “No Consequences or Impact” (191/604) and “No Clinical Signs or Symptoms” (124/604). The majority of reports originated from the United States (207), followed by Switzerland (47). Medical intervention was required in 286 cases. Of all reports, 263 described device malfunctions, and 319 reported patient injury.
CONCLUSIONS: Adverse events related to renal stents are more frequently reported in older adults, with device malfunctions and injuries comprising a significant portion of cases. These findings underscore the importance of continuous post-market surveillance, operator training, and patient counseling to mitigate risk and improve outcomes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD12
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Disease
Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain), Urinary/Kidney Disorders