Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis.

BACKGROUND AND AIMS: The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP. METHODS: We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023. RESULTS: From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%): 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.

Adverse Events of Endoscopic Clip Placement: A MAUDE Database Analysis.

BACKGROUND: Clips are endoscopic mechanical devices with tensile and closure strength that can approximate tissue and provide hemostasis through a tamponade effect. Clips are ubiquitously used in endoscopic practice, and numerous studies have validated the clinical efficacy of clips, with recent guidelines recommending them as a first-line intervention for recurrent and persistent nonvariceal gastrointestinal bleeding. However, the safety profile for these devices has yet to be delineated, thus, we aim to investigate this feature by examining the adverse events reported to the Food and Drug Administration. METHODS: Postmarketing surveillance data from the Food and Drug Administration Manufacturer And User Facility Device Experience database were analyzed from January 2012 to January 2021. The Manufacturer And User Facility Device Experience database is a reporting software and does not independently verify the details of complications. RESULTS: Two thousand five hundred forty reports were issued, of which 287 were patient adverse events and 2766 were device problems. Activation, separation, and positioning issues were most common. No consequences or clinically significant impact on patients were seen in 1968 reports. Foreign bodies were seen in 97 cases, hemorrhage in 57 cases, tissue damage in 42 cases, embedded clips in tissues/plaques in 16 cases, perforation in 15 cases, lacerations in 6 cases, and infection in 3 cases. CONCLUSIONS: While the most commonly reported device problems involved activation, separation, and positioning, most patients were clinically unaffected. Moreover, perforation and infection were exceedingly rare, further highlighting the safety profile of endoscopic clips.

Early (<4 weeks) versus standard (≥4 weeks) endoscopic drainage of pancreatic walled-off fluid collections: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Previous studies have demonstrated that the ideal time for drainage of walled-off pancreatic fluid collections is 4 to 6 weeks after their development. However, some pancreatic collections, notably infected pancreatic fluid collections, require earlier drainage. Nevertheless, the optimal timing of the first intervention is unclear, and consensus data are sparse. The aim of this study was to evaluate the clinical efficacy and safety of EUS-guided drainage of pancreatic fluid collections <4 weeks after development compared with ≥4 weeks after development. METHODS: Search strategies were developed for PubMed, Embase, and Cochrane Library databases from inception. Outcomes of interest were technical success, defined as successful endoscopic placement of a lumen-apposing metal stent; clinical success, defined as a reduction in cystic collection size; and procedure-related adverse events. A random-effects model was used for analysis, and results are expressed as odds ratio (OR) with 95% confidence interval (CI). RESULTS: Six studies (630 patients) were included in our final analysis, in which 182 patients (28.9%) were enrolled in the early drainage cohort and 448 patients (71.1%) in the standard drainage cohort. The mean fluid collection size was 143.4 ± 18.8 mm for the early cohort versus 128 ± 19.7 mm for the standard cohort. Overall, technical success was equal in both cohorts. Clinical success did not favor either standard drainage or early drainage (OR, .39; 95% CI, .13-1.22; P = .11). No statistically significant differences were found in overall adverse events (OR, 1.67; 95% CI, .63-4.45; P = .31) or mortality (OR, 1.14; 95% CI, .29-4.48; P = .85). Hospital stay was longer for patients undergoing early drainage compared with standard drainage (23.7 vs 16.0 days, respectively). CONCLUSIONS: Both early (<4 weeks) and standard (≥4 weeks) drainage of walled-off pancreatic fluid collections offer similar technical and clinical outcomes. Patients requiring endoscopic drainage should not be delayed for 4 weeks.

Patient adverse events and technical failures with the bravo capsule pH system: insights from the MAUDE database.

BACKGROUND: The BRAVO pH monitor system can benefit patients with ongoing GERD symptoms despite treatment and/or atypical symptoms. We aim to investigate the number and type of complications associated with the BRAVO pH capsule. METHODS: From April 2016 through February 2021, we analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. RESULTS: During the study period, approximately 1,651 reports were identified with 2391 cases associated with a device failure, and 254 reporting a patient-related adverse event. Most device complications were due to aspiration n = 153), followed by reported pain (n = 79), injury (unspecified) (n = 63), and additional radiologic imaging (n = 44). Laceration and bleeding accounted for 29 and 19 cases. Furthermore, three patients suffered perforation. Most device failures were due to loss or failure of the Bravo capsule to bond or adhere to the esophageal mucosa as planned (n = 1269), followed by an activation or positioning failure (n = 972), premature detachment of device (n = 284), and failure of the device to record or transmit data (n = 158). CONCLUSIONS: Findings from the MAUDE database highlight the risk of aspiration, hemorrhage/bleeding, perforation, injury, and retention as potential complications of BRAVO capsule placement.

Analysis of reported adverse events related to single-use duodenoscopes and duodenoscopes with detachable endcaps.

BACKGROUND AND AIMS: Single-use duodenoscopes and duodenoscopes with detachable/disposable caps emerged in the market to mitigate the risk of ERCP-related infections. We aimed to investigate adverse events associated with these devices occurring after U.S. Food and Drug Administration (FDA) approval. METHODS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. RESULTS: One hundred eighty-five reports comprising 201 device issues and 118 patient adverse events were identified from July 2018 through June 2021. Most device issues related to the single-use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the duodenoscope (2 reports), fluid leak (2 reports), and use-of-device problems (2 reports). Among the duodenoscopes with detachable/disposable caps, most device issues were related to bacterial contamination (53 reports), followed by issues with device use (31 reports), detachment/separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most frequently reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes with detachable/disposable caps were identified, of which Pseudomonas aeruginosa was most common. CONCLUSIONS: Findings from the MAUDE database highlight patient and device adverse events that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable/disposable caps. Whereas these devices mitigate the risk of transmitting infection, they are associated with additional device-associated adverse events.

Medications and the risk of perforated appendicitis: an adverse event report system (FAERS) database analysis.

OBJECTIVE: Different classes of medication have been reported in the literature to be associated with an increased risk of gastrointestinal perforation. However, little is known about the risk of drug-induced perforated appendicitis. METHODS: We analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS), a large national database of reported adverse events associated with post-market FDA-approved medications from January 2011 to October 2021. Patients of any age group with appendiceal perforation were included. Duplicated reports and other anatomical areas of gastrointestinal tract perforation outside the appendix were excluded. RESULTS: During the study period, 474 event cases met inclusion criteria, of which 284 were females. Most reports of perforation occurred in patients 40-49 years (n = 110) and 50-59 years (n = 144). Cases of perforated appendicitis occurred in patients being treated for multiple sclerosis (31.5%) and rheumatoid arthritis (17.1%). Perforation occurred in patients receiving interferon beta 1a (23.6%), adalimumab (17.9%), etanercept (14.1%), natalizumab (12.2%), clozapine (10.1%), infliximab (9.9%), bevacizumab (7.2%), and calcium chloride (4.9%). Sixteen fatal outcomes were reported. CONCLUSION: Findings from the FAERS database highlight the risk of appendiceal perforation in the context of different classes of drugs. Larger pharmacovigilance studies are needed to confirm these observations.