MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This file is being created to cover a complaint reference in the study: ¿fully-covered esophageal stent migration rates in benign and malignant disease: a multicenter retrospective study¿.The rate of clinically relevant migration as defined by stent migration followed by reintervention via endoscopy for stent replacement is unknown.The goal of this study is to gain insight into the total migration rate and clinically relevant migration rate of different types of fcsems placed within benign and malignant strictures with specific attention paid to stent manufacturer, diameter, and length.Multicenter retrospective analysis of endoscopic data from patients with fcsems placed within benign or malignant strictures.A total of 369 patients were included, 161 of whom had benign strictures and 208 of whom had malignant strictures.Replacement of a stent is indicated based on the degree of migration as well as clinical symptoms (i.E.Recurrence of dysphagia, pain, etc) and thereby an inability for the stent to perform its intended function, which we define as clinically relevant migration.The evolution stent (cook medical) which accounted for 55 (15%) of the stents placed.This file is being opened to address: "a total of 161 fcsems were placed within benign strictures (20 of the 161 stents were cook evolution devices).Of the 161 fully-covered self-expanding metal stents (fcsems), a total of 32 (20%) were noted to have a late complication that required stent replacement.One stent was replaced due to stent occlusion." as the study does not detail which manufacturer's stent resulted in stent occlusion, this complaint has been logged as there is a possibility that the stent was a cook evolution device.

Event Description

This file is being created to cover a complaint reference in the study: ¿fully-covered esophageal stent migration rates in benign and malignant disease: a multicenter retrospective study¿.The rate of clinically relevant migration as defined by stent migration followed by reintervention via endoscopy for stent replacement is unknown.The goal of this study is to gain insight into the total migration rate and clinically relevant migration rate of different types of fcsems placed within benign and malignant strictures with specific attention paid to stent manufacturer, diameter, and length.Multicenter retrospective analysis of endoscopic data from patients with fcsems placed within benign or malignant strictures.A total of 369 patients were included, 161 of whom had benign strictures and 208 of whom had malignant strictures.Replacement of a stent is indicated based on the degree of migration as well as clinical symptoms (i.E.Recurrence of dysphagia, pain, etc) and thereby an inability for the stent to perform its intended function, which we define as clinically relevant migration.The evolution stent (cook medical) which accounted for 55 (15%) of the stents placed.This file is being opened to address: "a total of 161 fcsems were placed within benign strictures (20 of the 161 stents were cook evolution devices).Of the 161 fully-covered self-expanding metal stents (fcsems), a total of 32 (20%) were noted to have a late complication that required stent replacement.One stent was replaced due to stent occlusion.As the study does not detail which manufacturer's stent resulted in stent occlusion, this complaint has been logged as there is a possibility that the stent was a cook evolution device.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: (b)(4).The evo- fully-covered esophageal stent device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.This file was created from the journal article to address the stent occlusion.It may be noted that the device in question are unknown and may or may not be evolution stents.Documents review including ifu review: as the evo fully-covered esophageal stent - unknown devices from unknown lot numbers, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo- (fully-covered esophageal stent) devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, ifu0061-5, which informs the user about the potential complications "additional complications include, but are not limited to : perforation, hemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.Customer complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This file is being created to cover a complaint reference in the study: ¿fully-covered esophageal stent migration rates in benign and malignant disease: a multicenter retrospective study.¿ the rate of clinically relevant migration as defined by stent migration followed by reintervention via endoscopy for stent replacement is unknown.The goal of this study is to gain insight into the total migration rate and clinically relevant migration rate of different types of fcsems placed within benign and malignant strictures with specific attention paid to stent manufacturer, diameter, and length.Multicenter retrospective analysis of endoscopic data from patients with fcsems placed within benign or malignant strictures.A total of 369 patients were included, 161 of whom had benign strictures and 208 of whom had malignant strictures.Replacement of a stent is indicated based on the degree of migration as well as clinical symptoms (i.E.Recurrence of dysphagia, pain, etc) and thereby an inability for the stent to perform its intended function, which we define as clinically relevant migration.The evolution stent (cook medical) which accounted for 55 (15%) of the stents placed.This file is being opened to address: "a total of 161 fcsems were placed within benign strictures (20 of the 161 stents were cook evolution devices).Of the 161 fully-covered self-expanding metal stents (fcsems), a total of 32 (20%) were noted to have a late complication that required stent replacement.One stent was replaced due to stent occlusion.As the study does not detail which manufacturer's stent resulted in stent occlusion, this complaint has been logged as there is a possibility that the stent was a cook evolution device.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.This file is being submitted to provide the below updates to the investigation evaluation previously submitted: as per the instructions for use, ifu0061-5, intended use section: ¿this device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.¿ root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the use of the device off-label if the device in question was an evo device.These devices are as per the instructions for use for malignant indication, the device in question was used for benign.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8715610
• MDR Text Key: 148528902
• Report Number: 3001845648-2019-00278
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/19/2019; 06/19/2019
• Supplement Dates FDA Received: 07/18/2019; 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention