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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

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

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.This international, multicenter, retrospective study analyzed consecutive patients undergoing eus-ge or duodenal stenting for goo between 2015 and 2021 in three european centers.Eus-ge had higher clinical success and lower stent dysfunction, with similar safety, compared with duodenal stenting, suggesting that eus-ge may be preferred over duodenal stenting in patients with malignant goo.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 will capture 1 case of stent migration that potentially occurred in the netherlands related files: 384241 - wanrooij, et al 2022 cholangitis and bleeding (netherlands), 384242 wanrooij, et al 2022 post-procedural pain (netherlands), 384245 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).Reportable cases in belgium and italy will be captured in this report.

Manufacturer Narrative

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 will capture 1 case of stent migration that potentially occurred in the netherlands.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 instructions for use, ifu0053 which accompanies this device, states ¿additional complications include but are not limited to: pancreatitis, intestinal perforation, pain, inadequate expansion, stent misplacement and/or migration, tumor ingrowth or overgrowth, stent occlusion, ulcerations, pressure necrosis, necrosis of the luminal mucosa, septicaemia, foreign body sensation, bowel impaction, death ( other than due to normal disease progression).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, stent migration is listed as a potential complication following the placement of this device.Summary of investigation: according to the pmcf study one complication of stent migration occurred.Confirmed quantity of 1 device, confirmed used.The patients 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, (ifu0053), stent migration is listed as a complication following the placement of this device.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 07-apr-2023.

• 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: 16204197
• MDR Text Key: 307682046
• Report Number: 3001845648-2023-00048
• 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: 04/07/2023

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: 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: 05/04/2023
• 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