P0679 - Analysis of Reported Adverse Events Related to The Use of The Through-The-Scope Endoscopic Suturing Device: An FDA MAUDE Database Study

Abdellatif Ismail, MD¹, Ayman Elawad, MD², Shaikhoon S. Mohammed, MD³, Mohanad Awadalla, MD⁴, Elmkdad E. Mohammed, MD⁵, Khalid Aloum, MD⁶, Hazem Abosheaishaa, MD⁷, Natalie Wilson, MD⁸, Tessa Herman, MD⁹, Monzer Abdalla, MD¹⁰, Khalid Ahmed, MD¹¹, Mohamed Abdallah, MD¹², Mohammad Bilal, MD^9
1University of Maryland Medical Center, Baltimore, MD; ²Massachusetts General Hospital, Boston, MA; ³Emory Clinic/Emory Healthcare, Atlanta, GA; ⁴Beth Israel Deaconess Medical Center, Boston, MA; ⁵The Wright Center for Graduate Medical Education, Scranton, PA; ⁶St. Barnabas Hospital, Bronx, NY; ⁷Icahn School of Medicine at Mount Sinai, Queens, NY; ⁸University of Minnesota, Minneapolis, MN; ⁹University of Minnesota and Minneapolis VA Health Care System, Minneapolis, MN; ¹⁰Ascension Saint Francis Hospital, Evanston, IL; ¹¹University of Pennsylvania, Philadelphia, PA; ¹²Cleveland Clinic, Cleveland, OH

Introduction: The X-Tack Endoscopic HeliX ® Tacking System is a through-the-scope (TTS) suturing device used to close defects in the gastrointestinal tract during endoscopy. The FDA approved the TTS suturing device X-Tack in January 2021 for use in managing fistulas, perforations, and closing defects following endoscopic submucosal dissection or endoscopic mucosal resection. The aim of this study is to analyze adverse events (AE) associated with the X-Tack device using the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: We analyzed the post-marketing surveillance data from the FDA MAUDE database for X-Tack from January 2021 through June 2024. We analyzed patient-related AEs and device-related problems. Additionally, we identified the type of procedure during which these events occurred, (Table 1).

Results: Twenty-three medical device reporting claims were identified. Due to insufficient data in two reports, we analyzed 21 claims. These included patient-related adverse events (n=13, 61.9%) and device-related problems (n=8, 38%). The most common patient-related adverse event was postoperative bleeding (n=5, 38.4%), followed by perforation (n= 2, 15%), abdominal pain (n=2, 15%), pancreatitis (n= 2, 15%), chest pain (n=1, 8%), and nausea/vomiting (n= 1, 8%).

One patient experienced a serious adverse event of bowel perforation following a technically successful mucosal defect closure in the ascending colon. The patient subsequently presented with abdominal pain, and colonic perforation was diagnosed, requiring exploratory laparotomy, right hemicolectomy, and cholecystectomy. In another claim, a patient experienced postoperative bleeding prompting repeat endoscopy for hemostasis. We realize that some of these adverse events may not be related to the use of the device itself. No additional claims provided details on management. The most common device-related problems were failure to deploy (n=2, 25%) and difficulty removal (n=2, 25%), followed by failure to open (n=1, 12.5%), suture damage (n=1, 12.5%), inadequate device anchoring (n=1, 12.5%), and damaged device (n=1, 12.5%), (Figure 1).

Discussion: Our analysis provides endoscopists with valuable information regarding common and rare patient related and device related issues with the X-Tack suturing device. However, due to the inherent nature of the database, there is not enough data to ascertain if these adverse events were secondary to use of the X-Tack suturing device or were related to the underlying clinical pathology.



Disclosures:


Abdellatif Ismail, MD¹, Ayman Elawad, MD², Shaikhoon S. Mohammed, MD³, Mohanad Awadalla, MD⁴, Elmkdad E. Mohammed, MD⁵, Khalid Aloum, MD⁶, Hazem Abosheaishaa, MD⁷, Natalie Wilson, MD⁸, Tessa Herman, MD⁹, Monzer Abdalla, MD¹⁰, Khalid Ahmed, MD¹¹, Mohamed Abdallah, MD¹², Mohammad Bilal, MD⁹. P0679 - Analysis of Reported Adverse Events Related to The Use of The Through-The-Scope Endoscopic Suturing Device: An FDA MAUDE Database Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.