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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Takamatsu 2022, the glasgow prognostic score and stricture site can predict prognosis after endoscopic duodenal stent placement for malignant gastric outlet obstruction endoscopic ds placements were performed under conscious sedation induced by an intravenous injection of midazolam and/or pentazocine.A lateral-viewing duodenal endoscope (tjf-260v, olympus medical systems, tokyo, japan) or a forward-viewing gastrointestinal endoscope (cf-h260ai, olympus medical systems, tokyo, japan) was used according to the site of the stricture.First, an endoscope was inserted at the proximal site of stenosis with a catheter, and a guidewire passed through the stricture.After confirming the site and length of duodenal stenosis with a contrast medium, the ds was deployed across the stricture under endoscopic and fluoroscopic guidance.According to the site and length of a stricture, a wallflex ds (6, 9, or 12cm in length, 22mm in body diameter; boston scientific, marlborough, ma, united states), niti-s ds (uncovered type 6, 8, 10, or 12cm in length, covered type 8 or 10cm in length, 22mm in body diameter; taewoong medical, seoul, korea) or evolution ds (6, 9, or 12cm in length, 22mm in body diameter; cook medical, winston-salem, nc, united states) was selected based on the endoscopist¿s preference.Evolution, which were all uncovered type, were used in 25 patients stent occlusion due to tumor ingrowth or overgrowth occurred in 19 of 135 patients (14.1%) during the observation period.Stent patency of 19 patients with stent occlusion was 66 (5¿418) days, and all patients suc-cessfully underwent endoscopic re-intervention with additional ds placement.5 of these patietns relate to the evoluation ds device.E.Require intervention/additional procedures s=4.80 male and 55 female patients.Average age 72 years.

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 25-may-2023.

Manufacturer Narrative

Pma/510(k) # k163468 device evaluation the device evaluation of the evolution duodenal controlled-release stent - uncovered of unknown rpn and lot number.Could not be completed as the device or photographic evidence of the device was not returned for evaluation.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 insert which accompanies this device, informs the user '' using this product may cause the following malfunctions and adverse events.Stent misplacement and/or migration and stent occlusion.There is no evidence to suggest that the customer did not follow the japanese insert.The japanese packaging insert c-es1405y03 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.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient¿s pre-existing condition.From the information provided it is known that the patients had malignant gastric outlet obstructions.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Summary of investigation according to the literature 5 cases of stent occlusion occurred.Confirmed quantity of 5 device, confirmed used.According to the literature, all patients successfully underwent endoscopic re intervention with additional stent placement.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: 16194038
• MDR Text Key: 307572100
• Report Number: 3001845648-2023-00042
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 06/26/2023
• 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