A0427 - Real World Experience of the Overstitch Endoscopic Suturing System: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database
Samuel Frost, MD1, Daryl Ramai, MD, MSc2, Douglas G. Adler, MD, FACG3 1Virginia Commonwealth University, Richmond, VA; 2University of Utah, Salt Lake City, UT; 3Centura Health-Porter Adventist Hospital, Salt Lake City, UT
Introduction: The Overstitch Endoscopic Suturing System allows for the placement of full thickness sutures endoscopically. The Overstitch system has been utilized in the closure of gastrocutaneous fistulas, mucosal defects following endoscopic submucosal dissection, perforations, and anastomotic leaks. Real-world data on the Overstitch system is sparse and no large studies describing common device failures and patient complications exist. We investigated the number and type of complications associated with the Overstitch device using a public-access governmental database.
Methods: Post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from October 2010 through Dec 2021 was analyzed for device failures and patient complications.
Results: During the study period, approximately 102 cases with 64 patient complications, 31 device failures, and 7 combined device failures with patient complications were identified. The most common patient complication was mucosal laceration (24.3%). The most common device failure was impaired tissue helix release (25%).
Discussion: The Overstitch system requires a complex multistep process for the placement of full-thickness sutures. A single misstep in the sequence of events can lead to device failure, patient complications, or a combination of both. The MAUDE database highlights common patient adverse outcomes and device failures thereby providing insight into potential areas for improvement of medical devices.
Disclosures:
Samuel Frost indicated no relevant financial relationships.
Daryl Ramai indicated no relevant financial relationships.
Douglas Adler: Boston Scientific – Consultant.
Samuel Frost, MD1, Daryl Ramai, MD, MSc2, Douglas G. Adler, MD, FACG3. A0427 - Real World Experience of the Overstitch Endoscopic Suturing System: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.
