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 Problem Obstruction/Occlusion (2422)

Event Date 07/21/2023

Event Type  Injury  

Event Description

Meyer et al 2023- wallflex® and evolution® duodenal stents have similar efficacy but different safety for malignant gastric outlet obstruction we included 129 patients: 74 received wallflex r stent and 55 received evolution stent.Included patients were followed up by until december 31, 2020.Between may 1, 2018 and june 30,2020, all patients had evolution duodenal (cook medical, winston-salem, nc, usa) all procedures were performed using therapeutic gastroscopes or duodenoscopes.All patients were sedated by the intravenous administration of sedatives.Both stents are non-biodegradable metal stents made of nitinol with a body diameter of 22 mm, a flar diameter of 27 mm, and a length of 6, 9, or 12 cm depending on the length of the stricture.Contrast material was injected to determine the length of the obstruction and the length of the stent to be used.Both stents are already preloaded on a 10f delivery system, inserted, and deployed over a 0.035-inch guidewire.After the deployment of each stent, its patency was verified by injecting the contrast material into the oral side of the location where the stent was deployed.Event description: stent obstruction / malfunction - two other patients underwent repeat endoscopy due to obstruction and evolution stent malfunction, due to tumor progression: one had a locally advanced pancreatic adenocarcinoma, and the other, a metastatic biliary adenocarcinoma.Repeat endoscopy 55 patients received an evolution stent.All consecutive patients older than 18 years of age, who underwent duodenal stent placements for malignant gastric outlet obstruction between (b)(6) 2013 and (b)(6), 2020, were included.Three patients were excluded because they were lost to follow-up after the procedure.

Manufacturer Narrative

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

• 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: 18265927
• MDR Text Key: 329721275
• Report Number: 3001845648-2023-00889
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2023

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/05/2023
• 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: 66 YR
• Patient Sex: Female