COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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Catalog Number UNKNOWN |
Device Problem
Material Perforation (2205)
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Patient Problem
Death (1802)
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Event Date 10/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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Pma 510(k) number: k162717.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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Title of literature review: ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017 major complications occurred in 14 patients (26.4%), including four (7.5%) with perforation of the 4 cases perforation, 3 deaths from mediastinitis or empyema caused by perforation.However as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 death from mediastinitis or empyema caused by perforation could have potentially been attributed to a cook evolution stent.Therefore, this file is created to capture 1 death from mediastinitis or empyema caused by perforation potentially related to a cook evolution stent.This is a conservative assessment.Clinical advisor ''three stent types were used in this study, i cannot confirm which stents cause the death'' therefore this is a conservative assessment three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment.
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Manufacturer Narrative
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Pma/510(k) # k162717.The evo (evolution® esophageal controlled-release stent - partially covered) 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, where three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this this specific adverse event.This file captures one death from mediastinitis or empyema caused by perforation.As the evo (evolution® esophageal controlled-release stent - partially covered) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo(evolution® esophageal controlled-release stent - partially covered 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, 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.As per medical advisor ''three stent types were used in this study, i cannot confirm which stents cause the death.'' and " it cannot be confirmed that cook stent caused the patient death." therefore due to limited information available it cannot be confirmed that cook stent caused the patient death.Complaint is confirmed based on customer testimony.According to the initial reporter, 1 death from mediastinitis or empyema caused by perforation.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Title of literature review: ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017.Major complications occurred in 14 patients (26.4%), including four (7.5%) with perforation of the 4 cases perforation, 3 deaths from mediastinitis or empyema caused by perforation.However as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 death from mediastinitis or empyema caused by perforation could have potentially been attributed to a cook evolution stent.Therefore, this file is created to capture 1 death from mediastinitis or empyema caused by perforation potentially related to a cook evolution stent.This is a conservative assessment.Clinical advisor ''three stent types were used in this study, i cannot confirm which stents cause the death'' therefore this is a conservative assessment.Three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this this specific adverse event so this is a conservative assessment.
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