MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number UNKNOWN

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

Patient Problems Inflammation (1932); Obstruction/Occlusion (2422); Pancreatitis (4481)

Event Date 04/18/2023

Event Type  Injury  

Event Description

Sakai, 2023 a novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study.In all the patients, sems placement was performed under conscious sedation by an experienced endoscopist at 12 hospitals.Semss were placed after endoscopic sphincterotomy.All semss were 10 mm in diameter, and their lengths (6 and 8 cm) were determined at the discretion of each hospital.The semss covered the biliary stenosis, and the lower end was placed across the papilla of vater.It was unclear whether the patient had been treated with a plastic stent or other biliary drainage procedures prior to sems placement.Malfunction/injury as outlined in below table: rbo: recurrent biliary obstruction (overall 49.3%) caused by: sludge obstruction (6.8%) (5/73).Recurrent biliary obstruction (overall 49.3%) caused by: other (4.1%) (3/73).Aes: pancreatitis in 9.6% (7/73).Cholecystitis in with reintervention 8.2% (2/73).Reintervention was performed in 47.9% for rbo (n=33).Reintervention was performed in cholecystitis (n=2).Medical advisor input: require intervention/additional procedures s=4.Patient info: age (yr) 72 (44¿93).Male 35 (47.9).Female 38 (52.1).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the device evaluation for the evolution biliary device of unknown lot could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was created from the attached journal article sakai et al 2023.This complaint was opened to capture 8 patients that experienced recurrent biliary obstruction (5 caused by sludge), 7 patients that experienced pancreatitis and 2 patients that experienced cholecystitis.Additional files listed were opened as a results of this paper: - (b)(4) / 3001845648-2023-00616: 16 cases chemotherapy/radiation post-procedure.- (b)(4) / 3001845648-2023-00618: 26 cases stent migration +user error.- (b)(4) / 3001845648-2023-00621: 4 cholecystitis & 4 cases cholangitis.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/label: the japanese packaging insert (c-es1608y02) supplied with the device instructs the user that ¿¿ significant adverse events that can occur in conjunction with biliary stent placement include but are not limited to: trauma to the biliary tract or duodenum ,perforation, obstruction of the pancreatic duct, stent migration, stent occlusion, ingrowth due to tumor or excessive hyperplastic tissue, tumor overgrowth stent misplacement, inflammation, recurrent obstructive jaundice, bile duct ulceration and death (other than due to normal disease progression).'' the japanese packaging insert (c-es1608y02) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined however a possible root cause can be attributed to known potential complications.The instruction for use lists recurrent biliary obstruction (covered in ifu by stent occlusion), pancreatitis and cholecystitis as potential adverse events associated with ercp.As per medial advisor input; obstruction/occlusion ¿possible root cause was related to patient malignant condition or reflux of duodenal contents into the stent.¿ pancreatitis: ¿it could be due to procedure, stent or patient pre-existing condition.¿ inflammation: ¿it could be due to the fully covered stent or patient pre-existing condition.¿ confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: this complaint was opened to capture 8 patients that experienced recurrent biliary obstruction , 7 patients that experienced pancreatitis and 2 patients that experienced cholecystitis.Confirmed quantity of 17 devices, confirmed used.The patient¿s required surgical required intervention/additional procedures.Investigation findings conclude that a possible root cause can be related to patient malignant condition or reflux of duodenal contents into the stent.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 30-nov-2023.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17507600
• MDR Text Key: 321072098
• Report Number: 3001845648-2023-00612
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K121430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 12/19/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female