Analysis of Reported Adverse Events With Colonic Stents: An FDA MAUDE Database Study.

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.

Adverse events associated with AXIOS stents: Insights from the manufacturer and user facility device experience database.

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.

Folie à Deux in the Setting of COVID-19 Quarantine.

We relay the case of a middle-aged male and his mother, an elderly female, who presented with folie à deux in the context of shared delusions of persecution and somatization during the COVID-19 quarantine period. The delusions were described as electric microwave shocks being transmitted to their internal organs by neighbors, followed by somatic symptoms of palpitations, headaches, and a shock-like perception. To the best of our knowledge, there have not been any reports that describe the development of folie à deux in the setting of the COVID-19 quarantine. Folie à deux may be defined as delusions affecting two or more individuals, usually first-degree relatives. Delusions classically transmit from one person, coined the inducer, to one or several individuals, the induced, who share and may expand on the communicated delusions. The preconditions that must exist for folie à deux to develop are an intimate emotional association between the inducer and the induced and a genetic predisposition to psychosis, such as blood relations with primary relatives. Isolation from society has also been considered a potential risk factor for shared psychosis in the recent literature. Given that to the best of our knowledge, there have not been any reports describing the development of folie à deux in the setting of the COVID-19 quarantine, the authors aim to dissect how extended periods of shared isolation from society during such a significant time in history may have served as a significant precipitating factor in the onset of shared psychotic disorder, while simultaneously illustrating a parallel relation to how such conditions may predispose certain subgroups to similarly dynamic-based mental health disorders. In addition, an evaluation of the origins and multifactorial etiology of folie à deux, along with that of existing treatment modalities, and the emphasis on advancement toward more effective treatment approaches will be provided.

Isotretinoin in Acne Vulgaris Complicated by Underlying Major Depression: A Case Report and Review of Literature.

We relay the case of a teenage female with severe facial acne vulgaris and a past psychiatric history of major depressive disorder who presented to the emergency department with a primary complaint of ongoing suicidal ideation. Defining features of this case stem from the patient endorsing that her suicidal ideation was a result of her severe acne and the coinciding social perturbation it caused. Additionally, the patient reported that just four months prior to the current presentation, her dermatologist started her on isotretinoin therapy for the management of acne vulgaris. To the best of the authors' knowledge, there have been no reported cases which describe a teenage female presenting with active suicidal ideation secondary to severe acne vulgaris while concurrently undergoing treatment with isotretinoin. Given the controversial but reported association between isotretinoin and increased suicidality, we considered the appropriateness of continuing this medication for our patient. We then conducted a literature search evaluating the evidence concerning this association. In what follows, we present a unique case report and provide a thorough review of the evidence-or lack thereof-surrounding the relationship between isotretinoin and suicidality. Additionally, the authors aim to provide recommendations for the management of future patients who may present under similar circumstances.

Complications 18 years after polyacrylamide hydrogel augmentation mammoplasty: a case report and histopathological analysis.

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.