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

Model Number TJF-260V

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

Patient Problems Obstruction/Occlusion (2422); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 10/17/2022

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature titled "the feasibility of whole-liver drainage with a novel 8 mm fully covered self-expandable metal stent possessing an ultra-slim introducer for malignant hilar biliary obstructions".Background: in the case of an unresectable malignant hilar biliary obstruction (mhbo), the optimal drainage method has not yet been established.Recently, an 8 mm, fully covered, self-expandable metal stent (fcsems) with an ultra-slim introducer has become available.In this article, the results of whole-liver drainage tests using this novel fcsems for mhbo are reported.Methods: unresectable mhbos up to bismuth iiia with strictures limited to the secondary branches were eligible.The proximal end of the stent was placed in such a way as to avoid blocking the side branches, and the distal end was placed above the papilla when possible.Consecutive patients treated between april 2017 and january 2021 were retrospectively analyzed.The technical and functional success rates, rates and causes of recurrent biliary obstruction (rbo), time to rbo (trbo), revision for rbo, and adverse events (aes) were evaluated.Results: eleven patients (bismuth i/ii/iiia: 1/7/3) were enrolled.Two stents were placed in nine patients and three were placed in two patients.Both the technical and functional success rates were 100%.Rbo occurred in four (36%) patients due to sludge formation.Revision was performed for three patients, with the successful removal of all stents.The median trbo was 187 days, and no late aes other than the rbo occurred.Regarding the distal position of the stent, the rbo rate was significantly lower (14.3% vs.75%, p = 0.041) and the cumulative trbo was significantly longer (median trbo: not reached vs.80 days, p = 0.031) in the case of the placement above the papilla than the placement across the papilla.Conclusion: for unresectable mhbos of bismuth i, ii, and iiia, whole-liver drainage with a novel 8 mm fcsems possessing an ultra-slim introducer was feasible and potentially safe, with favorable stent patency.Placement above the papilla might be preferrable to placement across the papilla.Type of adverse events/number of patients mild pancreatitis, resolved conventionally 2 patients recurrent biliary obstruction (rbo) 4 patients *deaths: due to the progression of the primary cancer 7 patients *note: the authors report the deaths were due to the progression of the primary cancer.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) (tjf-260v: evis lucera).(b)(6) (tjf-q290v: evis lucera elite).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

This supplemental report is being submitted to provided additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.The device history record was unable to be reviewed for this device since no product malfunction was reported.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it was presumed that the reported event is an accident or a complication associated with a surgical procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

• Brand Name: EVIS LUCERA 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: 15821550
• MDR Text Key: 303898075
• Report Number: 9610595-2022-04194
• 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
• Report Date: 12/20/2022

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-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/20/2022
• 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
• Treatment: NON-OLYMPUS 0.025-INCH HYDROPHILIC GUIDEWIRE.; NON-OLYMPUS CATHETER WITH A 0.025-INCH GUIDEWIRE.; NON-OLYMPUS VISIGLIDE2.
• Patient Outcome(s): Required Intervention; Other