Adverse Events of Endoscopic Clip Placement: A MAUDE Database Analysis

Area of Science:

• Gastroenterology
• Medical Devices
• Patient Safety

Background:

• Endoscopic clips are mechanical devices used for tissue approximation and hemostasis in gastrointestinal procedures.
• Clinical efficacy of endoscopic clips is well-established, with guidelines recommending them for nonvariceal gastrointestinal bleeding.
• The safety profile of endoscopic clips requires further investigation.

Purpose of the Study:

• To investigate the safety profile of endoscopic clips by analyzing adverse events reported to the Food and Drug Administration (FDA).

Main Methods:

• Analysis of postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
• Data collection spanned from January 2012 to January 2021.
• The MAUDE database does not independently verify reported complications.

Main Results:

• A total of 2,540 reports were analyzed, including 287 patient adverse events and 2,766 device problems.
• Most common issues were related to clip activation, separation, and positioning.
• While 1,968 reports had no significant patient impact, adverse events included foreign bodies (97), hemorrhage (57), tissue damage (42), embedded clips (16), perforation (15), lacerations (6), and infection (3).

Conclusions:

• Despite common device-related issues like activation and positioning problems, most patients experienced no clinical impact.
• Severe complications such as perforation and infection were rare, supporting the favorable safety profile of endoscopic clips.