MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

Model Number TJF-Q290V

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 09/21/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "efficacy of pancreatic duct stenting to prevent postendoscopic retrograde cholangiopancreatography pancreatitis after covered self-expandable metal stent deployment.Objectives: although covered self-expandable metal stents (csemss) are associated with the risk of postendoscopic retrograde cholangiopancreatography (ercp) pancreatitis due to pancreatic duct (pd) orifice obstruction, they are often used for biliary drainage treatment in malignant biliary obstruction (mbo).This study aimed to investigate the efficacy of pd stenting in preventing post-ercp pancreatitis after csems implantation.Methods: this retrospective cohort study analyzed 554 patients with transpapillary csems for mbo.Patients with noninitial deployment, benign disease, csems deployment above the papilla, surgically altered anatomy, uncovered self-expandable metal stents, multiple thin self-expandable metal stents, and unavailable procedure videos were excluded.Logistic regression analysis estimated the association between pd stenting and post-ercp pancreatitis incidence.We adjusted for age, sex, pancreatitis history, prophylactic rectal nonsteroidal anti-inflammatory drug use, naïve papilla, mbo etiology, and prolonged biliary cannulation time.Results: among 554 patients, 67 (12.1%) experienced post-ercp pancreatitis.Post-ercp pancreatitis was recorded in 13.7% of patients in the non-pd stenting and 4.3% in the pd stenting groups.Pancreatic duct stenting was associated with lower risks of post-ercp pancreatitis (odds ratio [or] 0.28; 95% confidence interval [ci] 0.099¿0.79; p=0.028).In multivariable analysis, the association between pd stenting and lower post-ercp pancreatitis incidence was consistent (or 0.19; 95% ci 0.062¿0.58; p=0.0034).Conclusions: pancreatic duct stenting could reduce the risk of post-ercp pancreatitis after csemss.Type of adverse events/number of patients.Pancreatitis n=67.Cholecystitis n=31.Cholangitis n=3.Bleeding n=3.Perforation n=1.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) 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 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 supplemental report is being submitted to provide additional information from the author (see b5).

Event Description

Additional information received from the author: in the medical opinion of the author, bleeding and perforation were associated with truetome (boston), other complications are procedure, and/or metalic stent related thus not related to olympus devices.

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 event 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 LUCERA ELITE 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: 16876461
• MDR Text Key: 314638428
• Report Number: 9610595-2023-07151
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/06/2023

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-Q290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/08/2023; 06/29/2023
• Supplement Dates FDA Received: 05/26/2023; 07/06/2023
• 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; Required Intervention