Background and Objectives: The AXIOS stent is indicated for transgastric or transduodenal drainage of symptomatic pancreatic pseudocysts and symptomatic walled off necrosis. The AXIOS stent functions as a conduit which allows solid and liquid pancreatic fluid collections (PFC) contents to pass into the luminal GI tract and also allows the passage of standard and therapeutic endoscopes into the PFC to perform endoscopic debridement. We aim to investigate the number and type of complications associated with AXIOS stents. Materials and Methods: We analyzed postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database January 2016 to February 2021. Results: During the study period, approximately 588 reports with 579 device issues and 250 patient complications were identified. Most device complications were due to stent positioning problems or stent malpositioning ( n = 206; 35.6%), followed by stent migration ( n = 72; 12.4%), premature deployment ( n = 61; 10.5%), material integrity ( n = 56; 9.6%), deployment failure ( n = 47; 8.1%), and difficulty removing the stent ( n = 45; 7.7%). The most reported patient adverse events were hemorrhage/bleeding ( n = 81; 32.4%), perforation ( n = 26; 10.4%), pain ( n = 22; 8.8%), unspecified infection ( n = 20; 8.0%), and death ( n = 17; 6.8%). Conclusions: Findings from the MAUDE database highlight patient and device complications which endoscopists should be aware of before AXIOS stent placement.

Polyacrylamide hydrogel (PAAG) is a synthetic substance previously used as an injectable material for augmentation mammoplasty. Current literature has demonstrated that the average time from PAAG injection to the onset of complication ranges from 6 to 39 months. We present a unique case report describing the onset of complications 18 years after PAAG augmentation mammoplasty. To the best of our knowledge, the presentation of a healthy female who experienced unprovoked expansion of breast tissue >15 years after polyacrylamide injection has not been previously reported in surgical literature. This suggests that serious complications of PAAG injection may occur later than the literature has previously described. Importantly, this case is the first demonstration of the successful surgical removal of polyacrylamide 18 years after injection. Additionally, this case also provides a histopathological analysis of breast capsules which showed evidence of an extensive chronic inflammatory reaction to polyacrylamide, consistent with previous reports.

Background: Colonic stents are indicated for preoperative and palliative decompression of large bowel obstruction. We aim to investigate post Food and Drug Administration (FDA) approval outcomes associated with colonic stents. Materials and Methods: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to December 2020. Results: During the study period, 691 device issues and 742 patient complications were identified. The number of adverse events reported to the FDA mildly increased from 6.40% in 2011 to 7.4% in 2020. Most device complications were due to a positioning problem (n=201, 29%), followed by device break (n=60, 8.6%), delamination (n=41, 6.3%), and migration or expulsion device (n=38, 5.55%). A number of reports described an unclassified adverse event without specifying device or operator problem (n=141, 20.3%). The most reported patient adverse events were perforation (n=150, 20.1%), death (n=47, 6.3%), abdominal pain/discomfort (n=27, 3.6%), and peritonitis (n=24, 3.2%). Conclusion: Findings from the MAUDE database highlight rare but important patient and device complications which endoscopists and referring providers should be aware of before consideration for colonic stent placement.

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