Olympus reviewed the following literature titled, "efficacy of pancreatic duct stenting to prevent postendoscopic retrograde cholangiopancreatography pancreatitis after covered self-expandable metal stent deployment.Objectives: although covered self-expandable metal stents (csemss) are associated with the risk of postendoscopic retrograde cholangiopancreatography (ercp) pancreatitis due to pancreatic duct (pd) orifice obstruction, they are often used for biliary drainage treatment in malignant biliary obstruction (mbo).This study aimed to investigate the efficacy of pd stenting in preventing post-ercp pancreatitis after csems implantation.Methods: this retrospective cohort study analyzed 554 patients with transpapillary csems for mbo.Patients with noninitial deployment, benign disease, csems deployment above the papilla, surgically altered anatomy, uncovered self-expandable metal stents, multiple thin self-expandable metal stents, and unavailable procedure videos were excluded.Logistic regression analysis estimated the association between pd stenting and post-ercp pancreatitis incidence.We adjusted for age, sex, pancreatitis history, prophylactic rectal nonsteroidal anti-inflammatory drug use, naïve papilla, mbo etiology, and prolonged biliary cannulation time.Results: among 554 patients, 67 (12.1%) experienced post-ercp pancreatitis.Post-ercp pancreatitis was recorded in 13.7% of patients in the non-pd stenting and 4.3% in the pd stenting groups.Pancreatic duct stenting was associated with lower risks of post-ercp pancreatitis (odds ratio [or] 0.28; 95% confidence interval [ci] 0.099¿0.79; p=0.028).In multivariable analysis, the association between pd stenting and lower post-ercp pancreatitis incidence was consistent (or 0.19; 95% ci 0.062¿0.58; p¿=¿0.0034).Conclusions: pancreatic duct stenting could reduce the risk of post-ercp pancreatitis after csemss.Type of adverse events/number of patients.Pancreatitis n=67.Cholecystitis n=31.Cholangitis n=3.Bleeding n=3.Perforation n=1.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(4) this medwatch report is for patient identifier (b)(4).There is no report of any olympus device malfunction in any procedure described in this study.
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Additional information received for this event: bleeding and perforation are from truetome (boston), others are from ercp procedures, metal stents, etc., and are unrelated to olympus equipment.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
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