Background and Aims
Duodenal stents are widely used to treat patients with malignant gastric outlet obstruction
(MGOO), most commonly from pancreatic cancer. The WallFlex (Boston Scientific, Natick,
Mass, USA) and Evolution (Cook Endoscopy, Winston-Salem, NC, USA) duodenal stents
are in widespread use for treating MGOO. The objective of this study was to analyze
device failures and patient-related adverse events reported to the U.S. Food and Drug
Administration (FDA) for these 2 stents.
Methods
We analyzed postmarketing surveillance data on the WallFlex and Evolution duodenal
stents from January 2000 to January 2022 through the FDA’s Manufacturer and User Facility
Device Experience (MAUDE) database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm).
Results
One hundred fifty-four MAUDE reports were identified and analyzed, from which 176
device failures and 186 patient-related adverse events were identified. Device-related
failures for the WallFlex stent were delivery system failure (15.4%) and failure to
activate the stent (13.2%). Device failures for the Evolution stent were failure to
activate the stent (16.5%) and delivery system failure (15.3%). Patient-related adverse
events for the WallFlex stent were perforation (18.9%), death (6.6%), and hemorrhage
(3.8%), whereas patient-related adverse events for the Evolution duodenal stent were
obstruction (16.3%), perforation (6.3%), aspiration (3.8%), and fragments of broken
delivery system left in the patient (3.8%).
Conclusions
Both stents are associated with device failures such as failure to activate the stent,
stent migration, and occlusion by tumor growth. Despite high success rates, duodenal
stents can be associated with serious device failures and patient-related adverse
events.
Graphical abstract
Graphical Abstract
Abbreviations:
FDA (U.S. Food and Drug Administration), MAUDE (Manufacturer and User Facility Device Experience), MGOO (malignant gastric outlet obstruction)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: October 07, 2022
Accepted:
October 4,
2022
Received:
August 9,
2022
Footnotes
DISCLOSURE: The following author disclosed financial relationships: D. G. Adler: Consultant for Boston Scientific. All other authors disclosed no financial relationships.
Identification
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© 2023 by the American Society for Gastrointestinal Endoscopy
