A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

The Counter Effect of Exercise on Cisplatin-Induced Cognitive and Proliferation Impairments.

Background Cisplatin, a widely used chemotherapeutic agent, offers therapeutic benefits for cancer treatment but often leads to adverse effects on neurogenesis and oxidative stress, causing cognitive impairment. Concurrent physical activity has been proposed as a potential strategy to counteract these side effects. This study aimed to investigate the impact of physical exercise on cisplatin-induced cognitive impairment in a mouse model. Methods Adult male mice (n=45) were divided into three groups: control, cisplatin-treated (2.3 mg/kg), and exercise/cisplatin. Cisplatin was administered intraperitoneally over one month, while the exercise/cisplatin group underwent moderate-intensity exercise alongside cisplatin treatment. Spatial memory was evaluated using the novel object recognition (NOR) task, and hippocampal proliferation and oxidative stress were examined using Ki-67 and glutathione peroxidase (GPx) immunohistochemistry (IHC) staining, respectively. Statistical analyses were performed using the GraphPad Prism 4.0 software (GraphPad Software, San Diego, CA). Results The cisplatin-treated mice exhibited significantly lower preference index (PI) scores in the NOR task compared to the control (p<0.001) and exercise/cisplatin (p<0.001) groups. IHC staining revealed impaired hippocampal proliferation and increased oxidative stress in the cisplatin-treated group relative to the control and exercise/cisplatin groups. The introduction of a moderate-intensity exercise protocol appeared to mitigate the decline in hippocampal proliferation and oxidative damage induced by cisplatin. Additionally, cisplatin-treated mice experienced weight loss, while exercise attenuated this effect. Conclusion Cisplatin treatment resulted in decreased memory, hippocampal proliferation, and weight loss in mice. Concurrent moderate-intensity exercise seemed to alleviate these effects, suggesting a potential role for physical activity in ameliorating cisplatin-induced cognitive decline. This study underscores the importance of incorporating exercise as a complementary strategy to enhance cognitive outcomes in cancer patients undergoing cisplatin treatment.