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 12/21/2022

Event Type  Injury  

Event Description

Sasaki, 2022 ¿ long-term outcomes of endoscopic double stenting using an anti-reflux metal stent for combined malignant biliary and duodenal obstruction.Purpose: to evaluate long-term outcomes of endoscopic double stenting using anti-reflux metal stents (arms) for combined malignant biliary and duodenal obstruction.Methods: consecutive patients with advanced pancreatic cancer who received endoscopic double stenting with self-expandable metal stents (sems) for combined malignant biliary and duodenal obstruction at our institution between july 2014 and march 2021 were evaluated.Patients were divided into the arms group, endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs) group, and covered metal stent-transpapillary (cms-transpapillary) groups.A duckbill-type metal stent was used in all arms cases.Three types of cms (all 10 mm in diameter) were used as conventional transpapillary stenting: (1)hanarostent biliary full cover neo (boston scientific japan, tokyo, japan), (2) niti-ssupremo (taewoong medical), and (3) evolution biliary controlled-release stent - fully covered (cook medical japan, tokyo, japan).Endoscopic procedure endoscopic retrograde cholangiopancreatography (ercp) was performed using a duodenoscope (jf-260v, tjf-260v, or tjf-q290v; olympus medical systems, tokyo, japan) under conscious sedation with pethidine and midazolam.Endoscopic duodenal stent placement was performed using either a duodenoscope or colonoscope (cf-hq290i; olympus medical systems).Eus-hgs was performed using a linear-type echoendoscope (gf-uct260; olympus medical systems) and eus-cds was performed using either a linear-type echoendoscope or a forward viewing echoendoscope (tgf-uc260j; olympus medical systems).Endoscopic biliary and duodenal stent placements were performed on separate occasions unless biliary and duodenal obstruction occurred simultaneously (video 1).Patients undergoing endoscopic double stenting were categorized into three groups depending on the procedure performed during the study period (fig.1).In the arms group, a duckbill-type metal stent was placed across the papilla in type iii obstruction (arms-transpapillary).In the case of type ii obstruction, eus-cds was performed from the duodenal bulb using a duckbill-type metal stent (arms-cds) and duodenal sems were placed in the second part of the duodenum.In the eus-hgs group, a partially covered sems was placed transmurally from the stomach in type ii and iii obstructions.In the cms-transpapillary group, a conventional cms was placed across the papilla in type iii obstruction.In the case of type ii obstruction, a cms was placed in a side-to-end fashion against duodenal sems.This complaint was opened to capture 1 patient that experienced stent occlusion after placement of an evo-b stent.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation the device evaluation of the evolution® duodenal controlled-release stent - uncovered 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 sasaki et al 2022.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 japanese packaging insert (c-es1405y03) which accompanies this device it informs the user '' using this product may cause the following malfunctions and adverse events , stent misplacement and/or migrations and stent occlusion.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.There is no evidence to suggest that the customer did not follow the packaging insert.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 to patient condition, as per the japanese packaging insert (c-es1405y03) which accompanies this device it informs the user '' using this product may cause the following malfunctions and adverse events , stent misplacement and/or migrations and stent occlusion.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Summary of investigation according to the literature stent occlusion was observed in 3 patients.Confirmed quantity of 3 device, confirmed used.The patient¿s outcome is unknown.Investigation findings conclude a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition, as per the japanese packaging insert (c-es1405y03) which accompanies this device it informs the user '' using this product may cause the following malfunctions and adverse events , stent misplacement and/or migrations and stent occlusion.It is known from the available information that the patient had pancreatic cancer.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

This supplemental report is being submitted due to the completion of the investigation on the 20-jun-2023 and corrections to the to reported used, patient details - age and gender, description of event and device name (common name and k number updated).This complaint was opened to capture 3 patient that experienced stent occlusion after placement of an evo-d stent.

• 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: 16205686
• MDR Text Key: 307695801
• Report Number: 3001845648-2023-00053
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: K101530
• 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: 06/20/2023

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
• 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: 07/19/2023
• 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: 56 YR
• Patient Sex: Female