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

Model Number	PBD-1033-0707
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus reviewed the following literature titled "real-life patency of plastic biliary stents in the pandemic era: is stent removal after 6 months safe and effective?" this retrospective study analyze the outcomes of patients who had delayed plastic biliary stent removal following endoscopic retrograde cholangiopancreatography (ercp) in the pandemic era.A total of 120 patients were included in the study.The mean time to stent removal was 4.9 ± 3.1 months (range 2-19): 3.5 ± 1.3 months (range 2-6) for cases with early removal and 8.6 ± 3.1 months (range 7-19) for delayed removal.Stent removal was successfully performed in all cases.Cases with early stent removal presented more frequently benign biliary strictures as the indication for plastic biliary stent insertion (25.9 vs 7.7%; p = 0.02).The delayed and early adverse events were statistically significant, specifically stent migration (20.5 vs 11.1%, p = 0.17), stent dysfunction (17.9 vs 13.6%, p = 0.53), obstructive jaundice (2.6 vs 0.0%, p = 0.33), acute cholangitis (10.3 vs 13.6%, p = 0.77), acute pancreatitis (0.0 vs 1.2%, p = 1.0), hospitalization (17.9 vs 14.8%, p = 0.66), or biliary pathology-related mortality (2.6 vs 1.2%, p = 0.55).In conclusion, delayed plastic biliary stent removal does not seem to have a negative impact on patients¿ outcomes.The plastic biliary stents referenced in this literature are either an olympus single use biliary drainage stent v - (pbd-1033-0707) or a non-olympus endo-flex stent.Stent dysfunction was defined as the presence of two of the three following criteria: (a) ultrasound showing new dilatation of intrahepatic or extrahepatic bile ducts; (b) bilirubin 2 mg/dl with an increase 1mg/dl compared to the value after initial successful drainage, or elevation of alkaline phosphatase/gamma-glutamyl transferase to more than twice the upper limit of normal values with an increase of at least 30 u/l; (c) signs of cholangitis (fever, abdominal pain, and leukocyte count >10.000/ll or c-reactive protein >20mg/dl).Seven patients with stent dysfunction were hospitalized.Type of adverse events/number of patients: event 1: stent migration - 17 patients, event 2: stent dysfunction - 18 patients, event 3: obstructive jaundice - 1 patient, event 4: acute cholangitis - 15 patients, event 5: acute pancreatitis / post-ercp pancreatitis - 1 patient, event 6: post-ercp bleeding - 3 patients, event 7: biliary pathology-related mortality - 2 patients, event 8: death of non-biliary related causes 18 patients.*for event 8, there is no relevance with the olympus device because it was a non-biliary cause death and was excluded from the study analysis.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6) - to capture event 1.(b)(6) - to capture events 2, 3, 4, 5 and 6.(b)(6) - to capture event 7.This medwatch report is for patient identifier (b)(6) (event 1, stent migration).
Additional Manufacturer Narrative
Since the literature described "double-pigtail (84.2%), 7.0 fr of width (52.5%), and 7 cm of length (64.2%) were the most frequent chosen stent features", olympus selected "pbd-1033-0707" as a representative product.The device was not returned for evaluation.The literature article is attached for additional information.Https://doi.Org/10.1080/00365521.2022.2164210.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Additionally, dhrs for over the past year prior to the date of occurrence were inspected and no deviations that could have caused or contributed to the reported issue were found.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The event can be detected/prevented by following the instructions for use which state: "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.The frequency rate for the stent dislocation is reported a 3.3% to 13.3%.Immediately remove the stent if dislocation is detected.Do not leave the instrument in the patient for a long time.Otherwise, the stent might be damaged." 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: 17817520
• Report Number: 9614641-2023-01398
• Device Sequence Number: 14992875
• Product Code: FGE
• UDI-Device Identifier: 04953170347320
• UDI-Public: 04953170347320
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PBD-1033-0707
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 08/27/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown