Evidence map›Paper›PMID 38580887›Full record

ArticleDigestive diseases and sciences2024

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

Fouad Jaber, Saqr Alsakarneh, Tala Alsharaeh, Ahmed-Jordan Salahat, Mohammad Jaber, Yazan Abboud, Mohammad Aldiabat, Khalid Ahmed, Mohamed Abdallah, Ala Abdel-Jalil and 3 more

Abstract read
PubMed Publisher
In one paragraph

Article in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Fouad JaberDepartment of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.
Saqr AlsakarnehDepartment of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.
Tala AlsharaehDepartment of Medical Education, Faculty of Medicine, The University of Jordan, Amman, Jordan.
Ahmed-Jordan SalahatDepartment of Medical Education, Faculty of Medicine, The University of Jordan, Amman, Jordan.
Mohammad JaberDepartment of Medical Education, Faculty of Medicine, Al-Azhar University, Gaza, Palestine.
Yazan AbboudDepartment of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
Mohammad AldiabatDepartment of Internal Medicine, Washington University in St. Louis, St. Louis, MO, USA.
Khalid AhmedDepartment of Internal Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Mohamed AbdallahDivision of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA.
Ala Abdel-JalilDivision of Gastroenterology and Hepatology, MetroHealth Medical Center, Cleveland, OH, USA.
Mohammad BilalDivision of Gastroenterology and Hepatology, University of Minnesota Medical Center, Minneapolis, MN, USA.
Monique BarakatDivision of Gastroenterology, Stanford University, Stanford, CA, USA.
Douglas G AdlerCenter for Advanced Therapeutic Endoscopy, Porter Adventist Hospital, Centura Health, Denver, CO, USA. Douglas.Adler.MD@adventhealth.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPancreatic 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).

methodsPost-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.

resultsA 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.

conclusionOur findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Indexed as

Databases, FactualPancreatic DuctsProduct Surveillance, PostmarketingProsthesis FailureStentsUnited States Food and Drug AdministrationCholangiopancreatography, Endoscopic RetrogradeEquipment FailureForeign-Body MigrationHumansPancreatitisUnited StatesAdverse eventsFDA MAUDE databasePancreatic duct stentsPost-market surveillance

Identifiers

PMID38580887

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.