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Background <p>The anchor-pronged clip has been widely adopted for closure of large defects, offering enhanced tensile strength and grasping ability. However, reported real-world device and patient adverse events are limited in literature. Our focus is to identify the most commonly reported adverse events, device issues, and their clinical implications.</p> Methods <p>The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was analyzed from February 1, 2023 to December 31, 2024 to report post-marketing surveillance data on these anchor pronged clips.</p> Results <p>Approximately 135 reported cases with 187 device issues and 30 patient adverse events were examined. The most reported device problems were due to activation, position, or separation (53.5%). Common indications included defect closures after endoscopic submucosal dissection (ESD) (29.9%) and endoscopic mucosal resection (EMR) (23.9%). From the total reports analyzed, patient adverse events were noted in 21.1% (<i>n</i> &#xa0;=&#xa0; 30) of cases which comprised of hemorrhage (43.3%; <i>n</i> &#xa0;=&#xa0; 13), perforation (10.0%; <i>n</i> &#xa0;=&#xa0; 3), abdominal pain (6.7%; <i>n</i> &#xa0;=&#xa0; 2) among others.</p> Conclusions <p>Our analysis of the MAUDE database suggests that the MANTIS<sup>™</sup> clip demonstrates a favorable safety profile, particularly considering its intended use for closing large defects after advance tissue resections and ulcerations – procedures that inherently carry a higher risk of complications. This study provides valuable insight to help inform the risk/benefit discussions with patients and guide the development of future design iterations, ultimately enhancing patient outcomes and safety.</p> Graphical abstract <p></p>

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Reported adverse events of the anchor prong clip: a MAUDE database analysis

  • 期刊论文

  • 发表日期：

    2026年2月10日

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  • Peter Bhandari,
  • Daryl Ramai,
  • Reanay Berezovskiy,
  • Celia Leone,
  • Azizullah Beran,
  • Sanjay M. Salgado,
  • Matthew A. Grossman

摘要

Background

The anchor-pronged clip has been widely adopted for closure of large defects, offering enhanced tensile strength and grasping ability. However, reported real-world device and patient adverse events are limited in literature. Our focus is to identify the most commonly reported adverse events, device issues, and their clinical implications.

Methods

The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was analyzed from February 1, 2023 to December 31, 2024 to report post-marketing surveillance data on these anchor pronged clips.

Results

Approximately 135 reported cases with 187 device issues and 30 patient adverse events were examined. The most reported device problems were due to activation, position, or separation (53.5%). Common indications included defect closures after endoscopic submucosal dissection (ESD) (29.9%) and endoscopic mucosal resection (EMR) (23.9%). From the total reports analyzed, patient adverse events were noted in 21.1% (n  =  30) of cases which comprised of hemorrhage (43.3%; n  =  13), perforation (10.0%; n  =  3), abdominal pain (6.7%; n  =  2) among others.

Conclusions

Our analysis of the MAUDE database suggests that the MANTIS™ clip demonstrates a favorable safety profile, particularly considering its intended use for closing large defects after advance tissue resections and ulcerations – procedures that inherently carry a higher risk of complications. This study provides valuable insight to help inform the risk/benefit discussions with patients and guide the development of future design iterations, ultimately enhancing patient outcomes and safety.

Graphical abstract