MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BILIARY BALLOON DILATOR

Model Number BD-210N-0620

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

Patient Problems Perforation (2001); Pancreatitis (4481)

Event Date 08/27/2022

Event Type  Injury  

Manufacturer Narrative

The literature described dilation of the stricture using a 12, 18, or 24f balloon dilation catheter.Olympus selected bd-210n-0620 as the representative model.The reported is related to the following linked patient identifiers.(b)(6).Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "scheduled endoscopic treatment of biliary anastomotic and nonanastomotic strictures after orthotopic liver transplantation".¿literature summary¿ background and aims: biliary strictures after liver transplantation are associated with significant morbidity and mortality.Although various endoscopic treatment strategies are available, consensus on a particular strategy is lacking.Moreover, the influence of endoscopic therapy on overall survival has not been studied.This retrospective study aimed to evaluate the impact of scheduled endoscopic dilatation of biliary strictures after orthotopic liver transplantation on therapeutic success, adverse events, and survival.Methods: between 2000 and 2016, patients with post-transplant anastomotic and nonanastomotic strictures were treated with balloon dilatation at defined intervals until morphologic resolution and clinical improvement.The primary clinical endpoint was overall survival, whereas secondary outcomes were technical and sustained clinical success, adverse events, treatment failure, and recurrence.Results: overall, 165 patients with a mean follow-up of 8 years were included; anastomotic and nonanastomotic strictures were diagnosed in 110 and 55 patients, respectively.Overall survival was significantly higher in patients with anastomotic strictures than in those with nonanastomotic strictures (median, 17.6 vs 13.9 years; log-rank: p <.05).Sustained clinical success could be achieved significantly more frequently in patients with anastomotic strictures (79.1% vs 54.5%, p <.001), and such patients showed significantly superior overall survival (19.7 vs 7.7 years; log-rank: p <.001).Sustained clinical success and the presence of nonanastomotic strictures were independently associated with better and worse outcomes (p <.05), respectively.Conclusions: scheduled endoscopic treatment of biliary anastomotic and nonanastomotic strictures after liver transplantation is effective and safe, with high success rates.The implementation of this strategy controls symptoms and significantly improves survival.¿type of adverse events/number of patients¿ the following events have been reported in the literature event1: procedure-related adverse events (52 patients) (the following events are included;) - bacterial cholangitis (40 patients) - post-ercp pancreatitis (12 patients) - bile duct perforation (4 patients event2: acute drug-induced liver failure (n = 1), graft failure because of hepatitis c recurrence (n = 1), or autoimmune hepatitis (n = 1) event3: died before reaching any endpoint because of ischemic gastric perforation (n = 1) and pneumonia (n= 1) event4: treatment failure occurred in 40 of 165 patients event5: retransplantation (32% vs 13.3%) event6: death (16% vs 13.3%) event7: died before receiving a graft (1 patient) regarding deaths the literature states as follows.-no patient died because of endoscopic procedure/related adverse events.Therefore, there is no association of deaths with the olympus device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide information received from the author b5.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.

Event Description

The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: SINGLE USE BILIARY BALLOON DILATOR
• Type of Device: BALLOON DILATOR
• 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: 18790378
• MDR Text Key: 336354481
• Report Number: 9614641-2024-00489
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143303
• 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: 03/21/2024

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
• Device Operator: Health Professional
• Device Model Number: BD-210N-0620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: METALIC STENT, BNL-10-060-180 SN -UNK; VISIGLIDE GUIDEWIRE , G-240-2545S, SN UNK
• Patient Outcome(s): Other