MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pancreatitis (4481)

Event Date 04/04/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "a prospective study of fully covered self-expandable metal stents for refractory benign pancreatic duct strictures." background: fully covered self-expanding metal stents (fcsemss) are a relatively novel option for treating painful main pancreatic duct refractory strictures in patients with chronic pancreatitis.Herein, we aimed to assess the efficacy, feasibility, and safety of fcsemss in this patient group.Methods: this prospective single-center study included patients who underwent endoscopic retrograde pancreatography with fcsems placement.The primary endpoints were the technical and clinical success rates.A reduction in visual analog scale pain score of >50% compared with that before stent placement was defined as clinical success.Secondary endpoints were resolution of pancreatic strictures on fluoroscopy during endoscopic retrograde pancreatography and the development of stent-related adverse events.Results: thirty-six patients were included in the analysis.The technical success rate was 100% (n=36) and the clinical success rate was 86.1% (n=31).There was a significant increase in stricture diameter from 1.7 mm to 3.5 mm (p<0.001) after stent removal.The mean visual analog scale pain score showed statistically significant improvement.At 19 months of follow-up, 55.6% of the patients were asymptomatic.Stent migration (16.7%), intolerable abdominal pain (8.3%), development of de novo strictures (8.3%), and mild pancreatitis (2.8%) were the most common adverse events.Conclusions: fcsems placement showed good technical and clinical success rates for achieving pain relief in patients with refractory main pancreatic duct strictures.Type of adverse events/number of patients: mild abdominal pain - 8 patients, intolerable abdominal pain - 3 patients, pancreatitis (mild) - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) (fg-v435p).(b)(6) (tjf-q180v).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.

Manufacturer Narrative

The model no.Of the product (dormia basket) was unknown but a representative product was chosen for processing purposes.(fg-v435p) the used stent during the procedure is not manufactured by olympus; based on the available information, it was determined that olympus devices did not likely cause or contribute to the 3 events; distal migration: 6 patients, stent-induced de novo ductal strictures: 3 patients and fcsems migration: 1 patient.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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 relationship between the device and the adverse events 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.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16508502
• MDR Text Key: 310950216
• Report Number: 9610595-2023-03981
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other