COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL
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Catalog Number UNKNOWN |
Device Problem
Migration (4003)
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Patient Problems
Perforation (2001); Obstruction/Occlusion (2422); Insufficient Information (4580)
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Event Date 06/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) # k163468.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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Takamatsu 2022, the glasgow prognostic score and stricture site can predict prognosis after endoscopic duodenal stent placement for malignant gastric outlet obstruction.Endoscopic ds placements were performed under conscious sedation induced by an intravenous injection of midazolam and/or pentazocine.A lateral-viewing duodenal endoscope (tjf-260v, olympus medical systems, tokyo, japan) or a forward-viewing gastrointestinal endoscope (cf-h260ai, olympus medical systems, tokyo, japan) was used according to the site of the stricture.First, an endoscope was inserted at the proximal site of stenosis with a catheter, and a guidewire passed through the stricture.After confirming the site and length of duodenal stenosis with a contrast medium, the ds was deployed across the stricture under endoscopic and fluoroscopic guidance.According to the site and length of a stricture, a wallflex ds (6, 9, or 12cm in length, 22mm in body diameter; boston scientific, marlborough, ma, united states), niti-s ds (uncovered type 6, 8, 10, or 12cm in length, covered type 8 or 10cm in length, 22mm in body diameter; taewoong medical, seoul, korea) or evolution ds (6, 9, or 12cm in length, 22mm in body diameter; cook medical, winston-salem, nc, united states) was selected based on the endoscopist¿s preference.Evolution, which were all uncovered type, were used in 25 patients this file will capture 1 case of jejunal perforation occurred 16 days after ds placement due to stent migration and 2 cases of stent migration.1 case in which a patient had technical failure due to stent migration immediately after stent placement.This patient was treated successfully with re-positioning of ds endoscopically on the next day.E.Require intervention/additional procedures s=4.80 male and 55 female patients.Average age 72 years.
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Manufacturer Narrative
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Pma/510(k) # k163468.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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Supplemental report being submitted due to the file being updated to remove reference to perforation following review of supplemental table available through the doi link.Takamatsu 2022, the glasgow prognostic score and stricture site can predict prognosis after endoscopic duodenal stent placement for malignant gastric outlet obstruction.Endoscopic ds placements were performed under conscious sedation induced by an intravenous injection of midazolam and/or pentazocine.A lateral-viewing duodenal endoscope (tjf-260v, olympus medical systems, tokyo, japan) or a forward-viewing gastrointestinal endoscope (cf-h260ai, olympus medical systems, tokyo, japan) was used according to the site of the stricture.First, an endoscope was inserted at the proximal site of stenosis with a catheter, and a guidewire passed through the stricture.After confirming the site and length of duodenal stenosis with a contrast medium, the ds was deployed across the stricture under endoscopic and fluoroscopic guidance.According to the site and length of a stricture, a wallflex ds (6, 9, or 12cm in length, 22mm in body diameter; boston scientific, marlborough, ma, united states), niti-s ds (uncovered type 6, 8, 10, or 12cm in length, covered type 8 or 10cm in length, 22mm in body diameter; taewoong medical, seoul, korea) or evolution ds (6, 9, or 12cm in length, 22mm in body diameter; cook medical, winston-salem, nc, united states) was selected based on the endoscopist¿s preference.Evolution, which were all uncovered type, were used in 25 patients.This file will conservatively capture 2 cases of stent migration relating to the cook evo device.1 case in which a patient had technical failure due to stent migration immediately after stent placement.This patient was treated successfully with re-positioning of ds endoscopically on the next day.E.Require intervention/additional procedures s=4.80 male and 55 female patients.Average age 72 years.
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Event Description
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Supplemental follow-up mdr report is being submitted due to the completion of the investigation on the 04-may-2023.
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Manufacturer Narrative
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Pma/510(k) # k163468.Device evaluation: the device evaluation of the evolution duodenal controlled-release stent - uncovered of unknown rpn and lot number could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file is related to (b)(4) emdr ref.- 3001845648-2023-00042).Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/label: the instructions for use which accompanies this device, informs the user about the "additional complications include, but are not limited to: pancreatitis, intestinal perforation, pain, inadequate expansion, stent misplacement and/or migration, tumour ingrowth or overgrowth, stent occlusion, ulcerations, pressure necrosis, erosion of the luminal mucosa, septicaemia, foreign body sensation, bowel impaction, death(other than duet to normal disease.".There is no evidence to suggest that the customer did not follow the instructions for use.The japanese packaging insert c-es1405y03 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Image review: an image was not returned for evaluation.Root cause analysis: 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 migration is listed as a complication following the placement of this device.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Confirmation of complaint : complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the literature 2 cases of stent migration occurred.1 case in which a patient had technical failure due to stent migration immediately after stent placement.Confirmed quantity of 2 device, confirmed used.According to the literature, the patients required intervention, the patient that had technical failure due to stent migration immediately after stent placement was treated successfully with re-positioning of ds endoscopically on the next day.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
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