P0003 - Adverse Events and Device Failures Associated With Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database

Fouad Jaber, MD¹, Saqr Alsakarneh, MD¹, Mohammad Jaber, MD², Khalid K. Ahmed, MD³, Azizullah Beran, MD⁴, Khaled Elfert, MD⁵, Ahmed Salih, MD⁶, Manasik Abdu, MD⁷, Yazan Abboud, MD⁸, Zubair Khan, MD⁹, Mohamed Ismail, DO⁸, Joseph Sleiman, MD¹⁰, Mohamed Abdallah, MD¹¹, Ala Abdel-Jalil, MD¹², Mohammad Bilal, MD^13
1University of Missouri-Kansas City, Kansas City, MO; ²Al-Azhar University, Gaza, Palestinian Territories; ³The Wright Center for GME, Scranton, PA; ⁴Indiana University, Indianapolis, IN; ⁵SBH Health System, Bronx, NY; ⁶Indiana University School of Medicine, Muncie, IN; ⁷University at Buffalo-Catholic Health System, Buffalo, NY; ⁸Rutgers New Jersey Medical School, Newark, NJ; ⁹Mercy Clinic, Poland, OH; ¹⁰UPMC Presbyterian, Pittsburgh, PA; ¹¹University of Minnesota Medical Center, Minneapolis, MN; ¹²Cleveland Clinic Foundation, Cleveland, OH; ¹³Minneapolis VA Medical Center, Minneapolis, MN

Introduction: Pancreatic duct stents (PDS) are widely used for the prevention of post-ERCP pancreatitis and for pancreatic endotherapy in chronic pancreatitis patients. Several commercially available PDS are commonly utilized. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA).

Methods: Post-marketing surveillance data from January 2010 to May 2023 were extracted from the FDA's MAUDE database to analyze the outcomes associated with PDS. Reports pertaining to the use of commonly used PDS including Advanix (Boston Scientfic), Geenan (Cook endoscopy), and Zimmon (Cook endoscopy) pancreatic stents were analyzed. The primary outcomes of interest were device problems and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with calculation of pooled numbers and percentages for each device and patient adverse event.

Results: During the study period, a total of 540 device problems and 582 patient-related adverse events were identified. Device failures (
Figure 1-A) were primarily attributed to device or usage problems (n=145, 26.9%), followed by off-label use (n=144, 26.7%), and material or component issues (n=120, 22.2%). The most common patient-related adverse events (Figure 1-B) were reported as having no harm or consequences to patients (n=400, 68.7%). Other reported patient adverse events included inflammation (n=24, 4.1%), perforation (n=16, 2.7%), foreign body presence (n=14, 2.4%), and pancreatitis (n=10, 1.7%). The highest number of device failures was associated with Zimmon pancreatic stents (n=217, 40.2%), followed by Geenen pancreatic stents (n=216, 40%) and Advanix (n=107, 19.8%). Device or usage problems were most frequently reported with the use of Zimmon stents (n=79, 36.4%), followed by Geenen stents (n=60, 27.8%).

Discussion: Most reported device-related issues were attributed to device or usage problems, and the majority of device failures did not result in harm to patients. Information from this study can be used in improving pancreatic duct stent designs for future iterations.



Disclosures:


Fouad Jaber, MD¹, Saqr Alsakarneh, MD¹, Mohammad Jaber, MD², Khalid K. Ahmed, MD³, Azizullah Beran, MD⁴, Khaled Elfert, MD⁵, Ahmed Salih, MD⁶, Manasik Abdu, MD⁷, Yazan Abboud, MD⁸, Zubair Khan, MD⁹, Mohamed Ismail, DO⁸, Joseph Sleiman, MD¹⁰, Mohamed Abdallah, MD¹¹, Ala Abdel-Jalil, MD¹², Mohammad Bilal, MD¹³. P0003 - Adverse Events and Device Failures Associated With Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.