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Updated: Feb 10, 2026

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents
Published on: October 26, 2016
[Medical Device Adverse Events Primary Analysis on Esophageal Stents]
Objective:
To probe into the characteristics and influencing factors of ADR cases induced by Esophageal stents, so as to provide effective resolutions for safety use. Methods
Methods:
By retrieving published MDR cases induced by Esophageal stents in FDA MAUDE database and CNKI database, 153 cases of adverse events in MAUDE database from 2012 to 2015 and 96 valid documents between 1994 and 2015 were obtained, screened and analyzed retrospectively.
Results:
The main MDR performance were gastrointestinal bleeding, chest pain, foreign body sensation, etc, due to the risk inherent in the product or risk during use.
Conclusion:
The public safety of Esophageal stents use can be ensued according to perfecting related laws, establishing and regulating the MDR monitor system and strengthening the responsibility of authority, manufacturers, suppliers and medical institutions.
Insights
This study analyzed esophageal stent adverse events, finding gastrointestinal bleeding and chest pain as common issues. Improving safety requires better regulations and monitoring systems for esophageal stent use.
Area of Science:
- Medical Device Safety
- Gastroenterology
- Clinical Research
Background:
- Esophageal stents are crucial for treating various conditions.
- Understanding adverse drug reactions (ADR) and medical device reports (MDR) is vital for patient safety.
Purpose of the Study:
- To investigate the characteristics and contributing factors of adverse events associated with esophageal stents.
- To propose strategies for enhancing the safe use of esophageal stents.
Main Methods:
- Retrospective analysis of 153 MDR cases from the FDA MAUDE database (2012-2015).
- Screening and analysis of 96 valid documents from the CNKI database (1994-2015).
Main Results:
- Common adverse events include gastrointestinal bleeding, chest pain, and foreign body sensation.
- Risks are associated with the inherent product characteristics and usage during medical procedures.
Conclusions:
- Enhancing public safety necessitates perfecting related laws and regulations.
- Establishing a robust MDR monitoring system and strengthening responsibilities among authorities, manufacturers, suppliers, and medical institutions are crucial.
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