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Background
Duodenal stents are widely used to treat patients with malignant gastric outlet obstruction,
most commonly from pancreatic cancer. The Wallflex and Evolution duodenal stents are
in widespread use for treating MGOO. The objective of this study is to analyze the
reported device failures and patient-related adverse events reported to the FDA for
these two stents.
Methods
We analyzed post-marketing surveillance data on the WallFlex Duodenal (Boston Scientific,
Natick, MA) and Evolution® Duodenal (Cook Endoscopy, Winston-Salem, NC) stents from
Jan 2000 to Jan 2022 through the FDA’s Manufacturer and User Facility Device Experience
(MAUDE) database. The MAUDE database can be accessed at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
Results
154 MAUDE reports were identified and analyzed. 176 device failures and 186 patient-related
adverse events were identified. Device related failures for the WallFlex stent include
delivery system failure (15.4%) and failure to activate the stent (13.2%). Device
failures for the Evolution stent include failure to activate the stent (16.5%) and
delivery system failure (15.3%). Patient-related adverse events for the Wallflex stent
include perforation (18.9%), death (6.6%) and hemorrhage (3.8%). Reports for the evolution
stent accounted for 43.0% of analyzed adverse events. Patient-related adverse events
for the Evolution Duodenal stent include obstruction (16.3%), perforation (6.3%),
aspiration (3.8%), and fragments of broken delivery system left in the patient (3.8%).
Conclusion
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.
Acronyms and Abbreviations:
MGOO (Malignant Gastric Outlet Obstuction), GJ (Gastrojejunostomy), TTS (Through-the-scope), MAUDE (Manufacturer and User Facility Device Experience), FDA (Food and Drug Administration), ICU (Intensive Care Unit), IRB (Institutional Review Board)To read this article in full you will need to make a payment
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Article Info
Publication History
Accepted:
October 4,
2022
Received in revised form:
September 24,
2022
Received:
August 9,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2022 by the American Society for Gastrointestinal Endoscopy
