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 Problems Fever (1858); Hemorrhage/Bleeding (1888); Necrosis (1971); Perforation (2001); Pneumonia (2011); Obstruction/Occlusion (2422); Gastrointestinal Hemorrhage (4476); Pancreatitis (4481)

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 the median time between initial diagnosis and duodenal stent placement was 3.5 months in 1998¿2009 and 6 months in 2010¿2019 (p = 0.54).Duodenal stent placement was technically successful in 143 of 147 patients (97%; 1998¿2009 vs.2010¿2019, 94% vs.100 %; p = 0.04).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, 100% vs.94 %;p = 0.01), 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 (72%), whereas the evolution duodenal stent was most frequently used in the period 2010¿ 2019 (91%; p < 0.001) (table 2).A statistically significantly higher rate of duodenal stents overlapping the papilla was observed in the period 1998¿2009 (34% vs.17%; p = 0.01).The percentage of patients who underwent drainage of the bile system prior to placement of the duodenal stent was comparable (74% vs.77%; p = 0.84).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.Major aes included fever (n = 14), cholangitis (n = 13), hemorrhage (n = 3), pneumonia (n = 3), deep venous thrombosis (n = 3), perforation (n = 2), pressure necrosis (n = 2), delirium (n = 1), and pancreatitis (n = 1).

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted as a correction report to capture updates made to the description of events on 28-jul-2023.¿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 = 0.54).Duodenal stent placement was technically successful in 143 of 147 patients (97%; 1998¿2009 vs.2010¿2019, 94% vs.100 %; p = 0.04).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, 100% vs.94 %;p = 0.01), 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 (72%), whereas the evolution duodenal stent was most frequently used in the period 2010¿ 2019 (91%; p < 0.001) (table 2).A statistically significantly higher rate of duodenal stents overlapping the papilla was observed in the period 1998¿2009 (34% vs.17%; p = 0.01).The percentage of patients who underwent drainage of the bile system prior to placement of the duodenal stent was comparable (74% vs.77%; p = 0.84).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.Major aes included cholangitis (n = 13), hemorrhage (n = 3), pneumonia (n = 3), perforation (n = 2), and pancreatitis (n = 1).¿.

Manufacturer Narrative

Pma/510(k) #k163468.Device evaluation: the 35x evolution duodenal stent system devices of unknown rpn and lot number involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to the journal article ¿reijm 2022 - self-expandable duodenal metal stent placement for the palliation of gastric outlet obstruction over the past 20 years¿ to capture ¿multiple adverse events¿.This complaint will capture the following: cholangitis (n=8), hemorrhage (n=2), pneumonia (n = 1), perforation (n = 1), and pancreatitis (n = 1), in/overgrowth of stent (n=21), food impaction (n=1).The following were also raised in response to this journal article: pr (b)(6) - reijm 2022 ¿ 1 death.Pr (b)(6) - reijm 2022 ¿ fever & pressure necrosis.Pr (b)(6) (emdr 3001845648-2023-00748) - reijm 2022 ¿ stent migration.Pr (b)(6) (emdr 3001845648-2023-00749) - reijm 2022 ¿ stent obstruction caused by external compression.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.An adverse event has been reported without a device problem.A device malfunction was not reported.Trending will monitor if any future investigation is required.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.Instructions for use and/label review: as per the ifu (ifu0053), cholangitis, pneumonia (covered as aspiration and infection), hemorrhage, perforation, pancreatitis, tumour in/overgrowth and food impaction (covered as stent occlusion) are all known potential adverse event 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.¿ as per medical advisors input ¿pneumonia is not listed in ifu, instead, aspiration and infection can cover the pneumonia¿ 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 known potential procedural adverse events with the use of an evolution duodenal stent system.All the above-mentioned adverse events that were associated with the reijm 2022 paper are known potential complications and listed as per the instructions for use (ifu0053).Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 35x used device.Summary of investigation: according to the initial reporter, the patient did experience adverse effects due to this occurrence.08x cases of cholangitis, 02x cases of haemorrhage, 01x case of pneumonia, 01x case of perforation, 01x case of pancreatitis, 01x case of food impaction (occlusion/obstruction), and 21x cases of in/overgrowth of stent were reported in the paper.Treatment for these ae¿s were not documented in the paper.As per medical advisor¿s clinical input, the treatment would have likely been reintervention/additional procedures.

Event Description

A supplemental report is being submitted due to completion of the investigation on the (b)(6) 2023 and the clarify updates made to this file on (b)(6) 2023 "this complaint will capture the following: cholangitis (n=8), haemorrhage (n=2), pneumonia (n = 1), perforation (n = 1), and pancreatitis (n = 1), in/overgrowth of stent (n=21), food impaction (n=1)".

• 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: 16206660
• MDR Text Key: 307734412
• Report Number: 3001845648-2023-00057
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

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?: No
• 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: 04/28/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/21/2022; 12/21/2022
• Supplement Dates FDA Received: 08/24/2023; 11/24/2023
• 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: 64 YR
• Patient Sex: Male