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

Model Number	PBD-1031-0711
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Peritonitis (2252); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 health effect - clinical code 4581 - appropriate term / code not available is used to reflect bile leakage.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 1.
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
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 reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.There was no complaint reported on the subject device and no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.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: 20397083
• Report Number: 9614641-2024-01956
• Device Sequence Number: 17707569
• 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): Unknown
• 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): 12/05/2024

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?: No
• 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: 11/29/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/05/2024
• 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 NO.; GF-UCT260/UNKNOWN SERIAL NO.; UNKNOWN 19- OR 22-GAUGE NEEDLE.; UNKNOWN GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown