COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Occlusion (1984); Obstruction/Occlusion (2422)
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Event Date 10/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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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.File created to capture 1 case of tumor overgrowth/ingrowth of stent that could have potentially been related to a cook evolution stent however we are unable to confirm, this is a conservative assessment.Literature review outlines overall 8 cases tumor overgrowth/ingrowth at proximal, distal and both ends of stent.However as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of tumor overgrowth/ingrowth at either proximal, distal and both ends of stent could have potentially been attributed to a cook evolution stent.As per literature review: ''4 cases tumor overgrowth observed at proximal end of stent, 1 cases tumor overgrowth observed at distal end of stent, 2 cases tumor overgrowth observed at both ends of stent'.' as per literature review, table 2 also shows there was 1 case of tumor ingrowth.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.Device evaluation: the partially covered evolution stent device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document-based investigation was conducted.Literature review outlines overall 8 cases tumor overgrowth/ingrowth at proximal, distal and both ends of stent.Only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of tumor overgrowth/ingrowth at either proximal, distal and both ends of stent could have potentially been attributed to a cook evolution stent.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.This file captures 1 case of tumor overgrowth/ingrowth of stent that could have potentially been related to a cook evolution stent.Documents review including ifu review: as the evo -pc- e device is from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo -pc- e 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, ifu0061-6, 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.Root cause review: 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, ingrowth due to tumor and tumor overgrowth are listed as potential complications information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Summary: customer complaint is confirmed based on customer testimony.The patient suffered tumor overgrowth/ ingrowth 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.File created to capture 1 case of tumor overgrowth/ingrowth of stent that could have potentially been related to a cook evolution stent however we are unable to confirm, this is a conservative assessment.Literature review outlines overall 8 cases tumor overgrowth/ingrowth at proximal, distal and both ends of stent.However as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of tumor overgrowth/ingrowth at either proximal, distal and both ends of stent could have potentially been attributed to a cook evolution stent.As per literature review: ''4 cases tumor overgrowth observed at proximal end of stent, 1 cases tumor overgrowth observed at distal end of stent, 2 cases tumor overgrowth observed at both ends of stent''.As per literature review, table 2 also shows there was 1 case of tumor ingrowth.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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