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COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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| Catalog Number UNKNOWN |
| Device Problem
Material Perforation (2205)
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| Patient Problem
Perforation of Esophagus (2399)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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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 esophageal perforation as the study does not detail which manufacturer's stent resulted in the esophageal perforation, this complaint has been logged as there is a possibility that the stent was a cook evolution device.
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Manufacturer Narrative
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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 esophageal perforation.As per medical advisor "however, please bear in mind that the wallflex stent (boston scientific) in this article has a rough flange comparing with cook stent and has caused perforations reported in some studies (documented in our rba).I know we have to consider the worst scenario, but it was possibly not cook stent.".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: stent misplacement and/or migration, perforation, hemorrhage, aspiration," 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, as per instructions for use, stent perforation is listed as a complication following the placement of this device.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.
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Event Description
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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 esophageal perforation as the study does not detail which manufacturer's stent resulted in the esophageal perforation, this complaint has been logged as there is a possibility that the stent was a cook evolution device.
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Event Description
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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 esophageal perforation as the study does not detail which manufacturer's stent resulted in the esophageal perforation, this complaint has been logged as there is a possibility that the stent was a cook evolution device.
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Manufacturer Narrative
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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).Importer site establishment registration number: 3005580113 multiple files have been opened in relation to this literature.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 attached journal article to address the esophageal perforation as per medical advisor "however, please bear in mind that the wallflex stent (boston scientific) in this article has a rough flange comparing with cook stent and has caused perforations reported in some studies.I know we have to consider the worst scenario, but it was possibly not cook stent." 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: stent misplacement and/or migration, perforation, hemorrhage, aspiration," 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, as per instructions for use, stent perforation is listed as a complication following the placement of this device.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.- attachment: [fully-covered esophageal stent migration rates-adler 2019.Pdf].
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Manufacturer Narrative
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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.
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Event Description
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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 esophageal perforation as the study does not detail which manufacturer's stent resulted in the esophageal perforation, this complaint has been logged as there is a possibility that the stent was a cook evolution device.
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