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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD; ESW PROSTHESIS, ESOPHAGEAL
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COOK IRELAND LTD; ESW PROSTHESIS, ESOPHAGEAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Integrity Problem (2978)
Patient Problem Erosion (1750)
Event Type  Injury  
Manufacturer Narrative
510(k) number cannot be provided as the exact rpn is unknown.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Literature review title: ¿¿predicators of esophageal self-expandable metal stent migration: an academic center study¿¿ jang et all 2016.Complaint received from internal personnel via e-mail on 20nov2019.As reported to customer relations: "stent erosion into broncho-pulmonary structures (confirmed by bronchoscopy and ct)." additional information from literature review jang et al 2016 added on 04-dec-2019 '' ''based on pre-determined definition of serious adverse event , 6 cases (5.7%) of serious adverse outcomes were reported'' including; ''2 cases of stent erosion into broncho-pulmonary structures (confirmed by brochoscopy and ct)''.The choice of stent type (fully covered vs partially covered), brand (wallflex® [boston sci-entific], evolution [cook medical, bloomington, in, usa], hanaro® [m.I.Tech, pyeongtaek, korea], and niti-s® [taewoong medical]), and size was determined by the performing endoscopist.
 
Event Description
Literature review title: ¿¿predicators of esophageal self-expandable metal stent migration: an academic center study¿¿ jang et all 2016.Complaint received from internal personnel via e-mail on 20 nov 2019.As reported to customer relations: "stent erosion into broncho-pulmonary structures (confirmed by bronchoscopy and ct)." additional information from literature review jang et al 2016 added on 04-dec-2019 '' ''based on pre-determined definition of serious adverse event , 6 cases (5.7%) of serious adverse outcomes were reported'' including; ''2 cases of stent erosion into broncho-pulmonary structures (confirmed by brochoscopy and ct)'' the choice of stent type (fully covered vs partially covered), brand (wallflex® [boston sci-entific], evolution [cook medical, bloomington, in, usa], hanaro® [m.I.Tech, pyeongtaek, korea], and niti-s® [taewoong medical]), and size was determined by the performing endoscopist.
 
Manufacturer Narrative
As the exact rpn is unknown these are the most likely us clearance numbers: k162717 or k093619 device evaluation: the evo (evolution esophageal metal stent ) 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.From (b)(6) 2013 to (b)(6) 2015, there were 154 cases (124 patients) of esophageal sems use in our institution.Of those, 105 cases (85 patients) met the inclusion criteria.Multiple stents from 4 different manufacturers were compared; wall-flex(boston scientific) with 67 cases, hanaro esophageal fc stents (m.I.Tech) with 18 cases, and niti fully covered stents (taewoong medical) in 11 cases and evolution esophageal stent (cook medical) in 9 cases.This file captures two cases stent erosion into broncho-pulmonary structures documents review including ifu review: as the evo (evolution esophageal metal stent) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (evolution esophageal metal stent) 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.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.A possible root cause could be attributed to patient condition related, as per instructions for use,esophageal ulceration and erosion are listed as a potential complication following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Manufacturer Narrative
510(k) number cannot be provided as the exact rpn is unknown.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Literature review title: ¿¿predicators of esophageal self-expandable metal stent migration: an academic center study¿¿ jang et all 2016.Complaint received from internal personnel via e-mail on 20nov2019.As reported to customer relations: "stent erosion into broncho-pulmonary structures (confirmed by bronchoscopy and ct)." additional information from literature review jang et al 2016 added on 04-dec-2019 '' ''based on pre-determined definition of serious adverse event , 6 cases (5.7%) of serious adverse outcomes were reported'' including; ''2 cases of stent erosion into broncho-pulmonary structures (confirmed by brochoscopy and ct)''.The choice of stent type (fully covered vs partially covered), brand (wallflex® [boston sci-entific], evolution [cook medical, bloomington, in, usa], hanaro® [m.I.Tech, pyeongtaek, korea], and niti-s® [taewoong medical]), and size was determined by the performing endoscopist.
 
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Type of Device
ESW PROSTHESIS, ESOPHAGEAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key9416446
MDR Text Key169412783
Report Number3001845648-2019-00671
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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