Major complications occurred in 14 patients (26.4%), including three (5.7%) with aspiration pneumonia.3 cases aspiration pneumonia mentioned in literature review, however as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of aspiration pneumonia with assumed intervention required could have potentially been attributed to a cook evolution stent.This file is created to capture 1 case of aspiration pneumonia with assumed intervention that could have potentially been related to a cook evolution stent, as this cannot be confirmed 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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Major complications occurred in 14 patients (26.4%), including three (5.7%) with aspiration pneumonia.3 cases aspiration pneumonia mentioned in literature review, however as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of aspiration pneumonia with assumed intervention required could have potentially been attributed to a cook evolution stent.This file is created to capture 1 case of aspiration pneumonia with assumed intervention that could have potentially been related to a cook evolution stent, as this cannot be confirmed 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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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.The literature review ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017 outlines major complications occurred in 14 patients (26.4%), including three (5.7%) with aspiration pneumonia 3 cases aspiration pneumonia mentioned in literature review, however as table 1 confirms only 1 cook evolution stent was used out of 53 which were used overall, therefore only 1 case of aspiration pneumonia with assumed intervention required 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 this specific adverse event so this is a conservative assessment.This file is created to capture 1 case of aspiration pneumonia with assumed intervention that could have potentially been related to a cook evolution stent, as this cannot be confirmed this is a conservative assessment.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.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.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, aspiration and infection are listed as a potential complication.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Therefore, risk will not be complete due to the limitation of available information.Summary: customer complaint is confirmed based on customer testimony.The patient had aspiration pneumonia with assumed intervention.Complaints of this nature will continue to be monitored for potential emerging trends.-.
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