MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)

Event Date 03/24/2022

Event Type  Injury  

Event Description

Wanrooij, et al 2022 ¿ endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison.Compared clinical success, safety, and stent dysfunction of eus-ge and duodenal stenting in patients with malignant gastric outlet obstruction (goo) using propensity score matching.214 patients underwent eus-ge (n = 107) or duodenal stenting (n = 107).After propensity score matching, 176 patients were matched and compared.Propensity score matching allocated 88 patients in each group (1:1), resulting in a total of 176 patients.Endoscopic duodenal stenting was performed under propofol sedation or general anesthesia.A therapeutic gastroscope or pediatric colonoscope was advanced to the site of gastric or duodenal obstruction.A double-lumen catheter and guidewire were then advanced through the stricture.Contrast injection under fluoroscopy was used to determine the length of the stricture, relation to the papilla, and preferable size of the stent.An uncovered self-expandable metal stent (sems) was then advanced over the wire and deployed under endoscopic and fluoroscopic guidance.Wallflex duodenal stents (boston scientific) and cook evolution duodenal stents (cook medical, bloomington, indiana,usa) 6, 9, and 12 cm in length were used.The diameter of the stent was 22mm in all cases.Adequate positioning of the stent was confirmed by means of fluoroscopy and endoscopy.This file is capture 4 cases of cholangitis and 3 cases of bleeding that potentially occurred in the netherlands.Related files: (b)(4) - wanrooij, et al 2022 cholangitis and bleeding (netherlands).(b)(4) wanrooij, et al 2022 post-procedural pain (netherlands).(b)(4) wanrooij, et al 2022 stent migration(netherlands).(b)(4) - wanrooij, et al 2022 cholangitis and bleeding (italy).(b)(4) - wanrooij, et al 2022 post-procedural pain (italy).(b)(4) - wanrooij, et al 2022 stent migration (italy).(b)(4) - wanrooij, et al 2022 cholangitis and bleeding (belgium).(b)(4) - wanrooij, et al 2022 post-procedural pain (belgium).(b)(4) - wanrooij, et al 2022 stent migration (belgium).Fda reportable cases in belgium and italy are captured in this report.

Manufacturer Narrative

Pma 510k #k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 23-mar-23 and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the device evaluation for evolution® duodenal 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 to capture 3 cases of bleeding and 4 cases of cholangitis that potentially occurred in the netherlands.The following files were also raised from this journal article: 384242 - wanrooij, et al 2022 post-procedural pain (netherlands).384245 ( emdr ref.- 3001845648-2023-00048) - wanrooij, et al 2022 stent migration(netherlands).385217 - wanrooij, et al 2022 cholangitis and bleeding (italy).385221 - wanrooij, et al 2022 post-procedural pain (italy).385223 - wanrooij, et al 2022 stent migration (italy).385218 - wanrooij, et al 2022 cholangitis and bleeding (belgium).385222 - wanrooij, et al 2022 post-procedural pain (belgium).385224 - wanrooij, et al 2022 stent migration (belgium).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: as per the instructions for use which accompanies this device informs the user that potential adverse events that are ¿¿ associated with gi endoscopy include, but are not limited to: airway obstruction , allergic reaction to contrast or medication, aspiration , biliary obstruction , cardiac arrhythmia or arrest, cholangitis, fever, haemorrhage, hypotension, infections, perforation, reflux and respiratory depression or arrest.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, haemorrhage and cholangitis are listed as a potential complication following the placement of this device.As per clinical input ¿¿ cholangitis is common, especially when the self-expanding metal stent (sems) is placed across the main duodenal papilla.When the duodenal stent is blocked from tumour ingrowth or debris defined as stent dysfunction in this article which would lead to a cholangitis.¿ summary of investigation: according to the literature paper 4 cases of cholangitis and 3 cases of bleeding occurred.Confirmed quantity of 7 device, confirmed used.The patient¿s outcome is unknown.Investigation findings conclude a definitive root cause was not established.A possible root cause could be attributed to the instructions for use haemorrhage and cholangitis are listed complications following the placement of this device.Cholangitis is common, especially when the self-expanding metal stent (sems) is placed across the main duodenal papilla.When the duodenal stent is blocked from tumor ingrowth or debris defined as stent dysfunction in this article which would lead to a cholangitis.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: 16204163
• MDR Text Key: 307678776
• Report Number: 3001845648-2023-00047
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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: 03/24/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 04/20/2023
• 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