P0388 - A Comprehensive Analysis of Reported Adverse Events With Boston Scientific WallFlex Esophageal Stents: An FDA MAUDE Database Study

Fouad Jaber, MD¹, Saqr Alsakarneh, MD¹, Azizullah Beran, MD², Laith Numan, MD, MS³, Mohammad Jaber, MD⁴, Thaer Abdelfattah, MD, MPH⁵, Rasheed Musa, MD⁶, Manasik Abdu, MD⁷, Abubaker Abdalla, MD⁸, Mohamed Ahmed, MD¹, Samuel Igbinedion, MD⁹, Ahmad Najdat Bazarbashi, MD^10
1University of Missouri-Kansas City, Kansas City, MO; ²Indiana University, Indianapolis, IN; ³Saint Louis University, St. Louis, MO; ⁴Al-Azhar University, Gaza, Palestinian Territories; ⁵Allegheny Health Network, Pittsburgh, PA; ⁶East Tennessee State University, Johnson City, TN; ⁷University at Buffalo-Catholic Health System, Buffalo, NY; ⁸Emory University, Atlanta, GA; ⁹Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; ¹⁰Washington University School of Medicine in St. Louis, St. Louis, MO

Introduction: The WallFlex Esophageal Stent from Boston Scientific is a self-expanding metal stent used to




maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events are limited. The aim of this study is investigate the reported adverse events and device failures associated with WallFlex esophageal stents using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: Data were analyzed from post-marketing surveillance data for the WallFlex Esophageal Stent ( both fully and partially covered) using the FDA's MAUDE database from January 2014 to May 2023. The primary outcomes were patient-related adverse events and intrinsic device malfunctions and/or failures. Secondary outcomes included the management of adverse events. Statistical analysis was performed using Microsoft Excel 2010. Pooled numbers and percentages were calculated for each adverse event on the device and patient.

Results: Over the timeframe of 10 years, only 140 device failures and 191 patient-related adverse events were reported. Device failures (Figure 1-A) were predominantly due to activation, positioning, or separation problems (n=52, 27.2%) and device detachment or migration (n=38, 19.9%). Most device failures were managed by removal of the stent and placing another WallFlex stent (n=41, 35.7%). The majority (n= 78, 55%) of patient-related adverse events (Figure 1-B) were asymptomatic (no harm or consequences to the patient). This is followed by no unviable codes (n=21, 15%), and dysphagia/odynophagia (n=12, 8.6%). Subgroup analysis comparing covered and partially covered stents revealed that covered stents had a higher frequency of activation, positioning, or separation problems (37.4% vs. 17%, p-value = 0.04). In comparison, partially covered stents had a higher frequency of device migration or detachment (23.4% vs. 19.2%, p-value = 0.07).

Discussion: The WallFlex stent has proven to be an effective device for the palliation and treatment of esophageal strictures with an overall low number of voluntary reported patient related adverse events or device malfunctions. This information should allow endoscopists to be more cognizant of device related malfunctions/failures and could potentially be used to optimize device design for future iterations.





Disclosures:


Fouad Jaber, MD¹, Saqr Alsakarneh, MD¹, Azizullah Beran, MD², Laith Numan, MD, MS³, Mohammad Jaber, MD⁴, Thaer Abdelfattah, MD, MPH⁵, Rasheed Musa, MD⁶, Manasik Abdu, MD⁷, Abubaker Abdalla, MD⁸, Mohamed Ahmed, MD¹, Samuel Igbinedion, MD⁹, Ahmad Najdat Bazarbashi, MD¹⁰. P0388 - A Comprehensive Analysis of Reported Adverse Events With Boston Scientific WallFlex Esophageal Stents: An FDA MAUDE Database Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.