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 Problem
Obstruction/Occlusion (2422)
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Event Type
Injury
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Manufacturer Narrative
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Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: as the rpn is unknown, providing both 510k numbers for partially and fully covered evolution esophageal devices, k162717, k093619.
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Event Description
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Literature review title: ''early pain detection and management after esophageal metal stent placement in incurable cancer patients: a prospective observational cohort study'' reijm et al 2016.Sixty-five patients were treated with a sems for a malignant stricture of the esophagus (n=58) or gastric tube (n=7), including 6 patients with a concomitant fistula.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (cook medical) and partially as well as fully covered wallflex stents (boston scientific).1 case food impaction in stent 3 days after stent placement and was treated with endoscopic cleaning ''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment moc 09-dec-2019.
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Manufacturer Narrative
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Pma/510(k)#: k162717.Device evaluation: the evo 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.A total of sixty five patients were identified in this study.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this this specific adverse event so this is a conservative assessment this file captures 1 case food impaction in stent 3 days after stent placement and was treated with endoscopic cleaning documents review including ifu review: as the evo (esophageal metal) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo(esophageal metal) 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.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, food bolus impaction is listed as a complication following the placement of this device.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: complaint is confirmed based on customer testimony.Patient required endoscopic cleaning for food impaction.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Literature review title: ''early pain detection and management after esophageal metal stent placement in incurable cancer patients: a prospective observational cohort study'' reijm et al 2016.Sixty-five patientswere treated with a sems for amalignant stricture of the esophagus (n=58) or gastric tube (n=7), including 6 patients with a concomitant fistula.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).1 case food impaction in stent 3 days after stent placement and was treated with endoscopic cleaning.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this this specific adverse event so this is a conservative assessment moc (b)(6) 2019.
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