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

Catalog Number UNKNOWN

Device Problems Collapse (1099); Activation Failure (3270)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/28/2022

Event Type  Injury  

Event Description

Reijm 2022 ¿ self-expandable duodenal metal stent placement for the palliation of gastric outlet obstruction over the past 20 years.Introduction duodenal stent placement is a palliative option for management of malignant gastric outlet obstruction (goo).In the last 20 years, management of gastrointestinal cancers has considerably changed.It is unknown if these changes have affected clinical outcome of duodenal stent placement.Duodenal stent placement: the median time between initial diagnosis and duodenal stent placement was 3.5 months in 1998¿2009 and 6 months in 2010¿2019 (p = (b)(4)).Duodenal stent placement was technically successful in (b)(4) of (b)(4) patients ((b)(4); 1998¿2009 vs.2010¿2019, (b)(4) vs.(b)(4); p = (b)(4)).Reasons for unsuccessful stent placement were inability to pass the guidewire (n = 2), unspecified technical issues (n = 1), and a percutaneous transhepatic drain extending into the duodenum that prevented the stent from deploying (n = 1).Most patients were treated under conscious sedation (1998¿2009 vs.2010¿2019, (b)(4) vs.(b)(4); p = (b)(4)), but propofol sedation and general anesthesia were also used in the period 2010¿2019.The wallflex duodenal stent was the most frequently used stent in the period 1998¿2009 ((b)(4)), whereas the evolution duodenal stent was most frequently used in the period 2010¿ 2019 ((b)(4); p < (b)(4)) (table 2).A statistically significantly higher rate of duodenal stents overlapping the papilla was observed in the period 1998¿2009 ((b)(4) vs.(b)(4); p = (b)(4)).The percentage of patients who underwent drainage of the bile system prior to placement of the duodenal stent was comparable ((b)(4) vs.(b)(4); p = (b)(4)).Duodenal stent placement was performed under fluoroscopic guidance and according to standard procedures.During stent placement, patients were under conscious sedation, propofol sedation, or general anesthesia.Selection of the most appropriate stent design and length was based on the judgement and preference of the endoscopist.Biliary stent placement was performed before duodenal stent placement depending on biliary patency and stricture location.This complaint will capture 02x of obstruction caused by external compression on duodenal stent.As per medical advisor¿s input, this was caused by inadequate expansion of the stent resulting in reoccurrence of patient symptoms (goo).

Manufacturer Narrative

Investigation still ongoing.A final mdr will sbe submitted up completion of the investigation.

Manufacturer Narrative

Pma/510(k) # k163468 device evaluation: the 02 x evolution® duodenal controlled-release stents of unknown lot number and rpn involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to the journal article ¿self-expandable duodenal metal stent placement for the palliation of gastric outlet obstruction over the past 20 years¿ to capture ¿02x cases of stent obstruction caused by external compression¿.The following were also raised in response to this journal article: pr (b)(6) - reijm 2022 ¿ 1 death pr (b)(6) - reijm ¿ multiple aes pr (b)(6) - reijm 2022 ¿ fever & pressure necrosis (emdr# 3001845648-2023-00057) pr (b)(6) - reijm 2022 ¿ stent migration (emdr# 3001845648-2023-00748) the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: 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.Historical data review: historical data was not reviewed as the lot number is unknown.Instructions for use and/label review: as per the ifu (ifu0053), stent obstruction/occlusion and inadequate expansion are known potential adverse events associated with gi endoscopy ¿those associated with gi endoscopy include, but are not limited to: airway obstruction, allergic reaction to contrast to medication, aspiration, biliary obstruction, cardiac arrhythmia or arrest, cholangitis, fever, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest." ¿additional complications include, but are not limited to: allergic reaction to nickel, bowel impaction, death (other than due to normal disease progression.), erosion of the luminal mucosa, foreign body sensation, inadequate expansion, intestinal perforation, nausea/vomiting, pain/discomfort, pancreatitis, pressure necrosis, septicemia, stent misplacement and/or migration, stent occlusion, tumour ingrowth or overgrowth, ulcerations.¿ there is no evidence to suggest that the customer did not follow the instructions for use or product label.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 the patients pre-existing conditions and/or anatomy.As per clinical input, external compression from the tumour outside the duodenum on the stent may have caused the stent to inadequately expand resulting stent obstruction and subsequent recurrence of patient symptoms.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter, the patient did experience an adverse effect due to this occurrence.As per the journal article, the patients experienced recurrence of goo symptoms due to the stent dysfunction mentioned above.It is unknown how the patients were treated.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2024.

• 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: 17843686
• MDR Text Key: 324591122
• Report Number: 3001845648-2023-00749
• 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
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 04/28/2022
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2022
• 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: 64 YR
• Patient Sex: Male