MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BILIARY DRAINAGE STENT V

Model Number	PBD-1031-0711
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "safe performance of track dilation and bile aspiration with ercp catheter in eus-guided hepaticogastrostomy with plastic stents: a retrospective multicenter study." literature summary abstract objectives: endoscopic-ultrasound-guided hepaticogastrostomy (eus-hgs) with plastic stent placement is associated with a high incidence of adverse events that may be reduced using an endoscopic retrograde cholangiopancreatography (ercp) contrast catheter in the track dilation step.In this study, we evaluated the usefulness of track dilation and bile aspiration performed with an ercp contrast catheter in eus-hgs with plastic stent placement.Methods: in a multicenter setting, 22 eus-hgs cases dilated with an ercp contrast catheter were analyzed retrospectively and compared between a bile aspiration group and no bile aspiration group.Rbo was defined as the recurrence of obstructive jaundice and/or cholangitis due to stent occlusion or migration.Adverse events other than rbo were categorized as post-procedure complications, which included bile leakage, peritonitis, bleeding, perforation, pancreatitis, cholecystitis, aspiration pneumonia, liver abscess, mediastinal emphysema, and pneumoperitoneum.These complications were categorized as early (within 30 days) or late (at 31 days or later).The time point of adverse events was defined as the point when symptoms associated with these conditions were observed.Results: overall, adverse events occurred in three (13.6%) cases of bile leakage, three (13.6%) cases of peritonitis, and one (4.5%) case of bleeding.Comparing patients with and without bile aspiration, 6 of the 11 patients (54.5%) with no bile aspiration had adverse events, whereas only 1 of the 11 patients (9.1%) who had bile aspiration, as much bile as possible, had an adverse event (bleeding).In univariate analysis, the only factor affecting the occurrence of adverse events was bile aspiration whenever possible (odds ratio, 12.0; 95%ci 1.12¿128.84).Rbo was observed in seven patients (35.0%).The cause of rbo was sludge formation in four patients, migration (toward the gastric side) in one patient, and another cause in two patients.Two patients underwent stent exchange on days 112 and 119, prior to the onset of rbo, and were treated as censored for statistical purposes.Median trbo was 365 (range, 3¿382) days.Adverse events other than rbo included bile leakage in three patients (13.6%), peritonitis in three patients (13.6%), and bleeding in one patient (4.5%), all of which were mild, occurred early, and were relieved by conservative treatment.Conclusions: in eus-hgs with plastic stent placement, track dilation and bile aspiration with an ercp contrast catheter may be useful in reducing adverse events.Type of events/number of patients event 1: serious adverse events bile leakage (3 patients) peritonitis (3 patients) bleeding (1 patient).Event 2: reportable malfunction with serious adverse event stent migration causing recurrent biliary obstruction (1 patient).
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifiers: (b)(6).This mdr is submitted for event 2.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide an update to field d8.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the reported event occurred due to the stent may have migrated into the bile duct due to the patient's internal environment, including chemical effects from digestive fluids and mechanical effects from peristalsis during implantation.Furthermore, it is likely that the reported event is an accident, or a complication associated with a procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.However, the subject device was not returned, and the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: "the operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual, therefore, does not explain or discuss clinical endoscopic procedures." "after placing the stent in the duct, closely monitor the condition of the patient.Also, periodically check the condition of the stent (to see if the lumen of the stent is not clogged, etc.) and the condition of implantation of the stent (to see if the position of the stent has not changed).In case of irregularities or unnecessary retention of the stent, remove the stent using grasping forceps.If necessary, periodically exchange the stent.The stent may deteriorate over time and could become clogged.The status of the stent can change with the condition of the patient (e.G., inflammation, remittence of biliary tract stenosis etc.).The stent may deteriorate over time, causing the side flap to break or detach completely (reports have been received on side flaps coming off several months after placement).Deterioration or damage to the stent may result in erosion of the duodenal wall, biliary tract obstruction, detachment of the stent part migrating into the duct or out of the papilla, mucous membrane damage, perforation, or bleeding." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BILIARY DRAINAGE STENT V
• Common Device Name: SINGLE USE BILIARY DRAINAGE STENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20397085
• Report Number: 9614641-2024-01957
• Device Sequence Number: 15018116
• Product Code: FGE
• UDI-Device Identifier: 04953170346439
• UDI-Public: 04953170346439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PBD-1031-0711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERCP CATHETER, 1.6; GF-UCT240-AL5/UNKNOWN SERIAL NUMBER; GF-UCT260/UNKNOWN SERIAL NUMBER; UNKNOWN 19- OR 22-GAUGE NEEDLE; UNKNOWN GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown