Olympus reviewed the following literature titled "eus-guided gastroenterostomy versus duodenal self-expandable metal stent for malignant gastric outlet obstruction: results from a nationwide multicenter retrospective study (with video)." this multicenter, observational study of d-sems and eus-ge procedures for patients with malignant goo was conducted in 97 patients.There were no statistically significant differences regarding technical (92.8% vs 93.7%) or clinical success (83.5% vs 92.4%) were found.Patients in the eusge group had improved stent patency when compared with those patients in the duodenal self-expandable metal stent (d-sems) group at 3 months (92.23% vs 80.6%; adjusted hazard ratio,.37; p z.033).This study concludes that eus-guided gastroenterostomy (eus-ge) seems to have improved patency outcomes when compared with d-sems placement for palliative treatment of malignant gastric outlet obstruction (goo).Type of adverse events/number of patients, [duodenal self-expandable metallic stent] , bleeding - 1 patient, perforation - 3 patients, pancreatitis and/or cholangitis - 4 patients, severe pain - 1 patient, death- 1 patient.[eus-guided gastroenterostomy], bleeding - 21 patients, perforation - 1 patient, misdeployment - 3 patients, severe pain - 1 patient, death- 1 patient.This literature article requires 8 reports.The related patient identifiers are as follows: (b)(6): gif-1th190 (ae), (b)(6): gif-1th190 (death), (b)(6): gf-uct180 (ae), (b)(6): gf-uct180 (death), (b)(6): pbd-v813w-07 (ae), (b)(6): pbd-v813w-07 (death), (b)(6): b-v232p-a (ae), (b)(6): b-v232p-a (death).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
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This supplemental report is being submitted to provide additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5, d4, e2, g4 and h6.The device history record was unable to be reviewed for this device since the serial / 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.Olympus will continue to monitor field performance for this device.
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