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Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.
Jaber, Fouad; Alsakarneh, Saqr; Alsharaeh, Tala; Salahat, Ahmed-Jordan; Jaber, Mohammad; Abboud, Yazan; Aldiabat, Mohammad; Ahmed, Khalid; Abdallah, Mohamed; Abdel-Jalil, Ala; Bilal, Mohammad; Barakat, Monique; Adler, Douglas G.
Afiliación
  • Jaber F; Department of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.
  • Alsakarneh S; Department of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.
  • Alsharaeh T; Department of Medical Education, Faculty of Medicine, The University of Jordan, Amman, Jordan.
  • Salahat AJ; Department of Medical Education, Faculty of Medicine, The University of Jordan, Amman, Jordan.
  • Jaber M; Department of Medical Education, Faculty of Medicine, Al-Azhar University, Gaza, Palestine.
  • Abboud Y; Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
  • Aldiabat M; Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, USA.
  • Ahmed K; Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA.
  • Abdallah M; Department of Internal Medicine, University of Pennsylvania, Philadelphia, PA, USA.
  • Abdel-Jalil A; Division of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA.
  • Bilal M; Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Cleveland, OH, USA.
  • Barakat M; Division of Gastroenterology and Hepatology, University of Minnesota Medical Center, Minneapolis, MN, USA.
  • Adler DG; Minneapolis Veterans Affairs Health Care System, Minneapolis, MN, USA.
Dig Dis Sci ; 69(6): 2018-2025, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38580887
ABSTRACT

INTRODUCTION:

Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. 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 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event.

RESULTS:

A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events.

CONCLUSION:

Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Conductos Pancreáticos / Vigilancia de Productos Comercializados / United States Food and Drug Administration / Falla de Prótesis / Stents / Bases de Datos Factuales Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Dig Dis Sci Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Conductos Pancreáticos / Vigilancia de Productos Comercializados / United States Food and Drug Administration / Falla de Prótesis / Stents / Bases de Datos Factuales Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Dig Dis Sci Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos