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 Problem Inflammation (1932)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

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

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.4 cholecystitis without reintervention, cholecystitis in 8.2% (6/73).4 cases cholangitis, non-occlusive cholangitis in 5.5% (4/73).Medical advisor input: conservative treatment only (antibiotics and/or no oral intake) s=3.Conservative treatment only (antibiotics and/or no oral intake) s=3.Patient info: -age (yr) 72 (44¿93), -male 35 (47.9), -female 38 (52.1).

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 4 patients that experienced cholecystitis and 4 patients that experienced cholangitis.Additional files listed were opened as a results of this paper: (b)(4) : 17 cases of recurrent biliary obstruction (rbo) & aes (emdr 3001845648-2023-00612).(b)(4) : 16 cases chemotherapy/radiation post-procedure (emdr 3001845648-2023-00616).(b)(4) : 26 cases stent migration +user error (emdr 3001845648-2023-00618).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 ¿¿ potential significant adverse events associated with ercp include, but are not limited to pancreatitis,cholangitis,cholecystitis,cholestasis,aspiration,perforation,hemorrhage,infection,sepsis,allergic reaction to contrast or medication, hypotension, respiratory depression or arrest and cardiac arrhythmia or arrest.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.A possible root cause can be attributed to known potential adverse events of using the device and patient pre-existing condition.The japanese packaging insert lists cholecystitis and cholangitis as potential adverse events associated with ercp.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: according to the literature 4 patients experienced cholecystitis and 4 patients experienced cholangitis.Confirmed quantity of 8 devices, confirmed used.The patient¿s required medication to treat the cholecystitis cholangitis.Investigation findings conclude that a possible root cause can be attributed to known potential complications associated with ercp.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 28-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: 17508257
• MDR Text Key: 320885850
• Report Number: 3001845648-2023-00621
• 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: 11/28/2023

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 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: 12/18/2023
• 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