MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Dysphasia (2195)

Event Type  Injury  

Manufacturer Narrative

510(k) number cannot be provide as the rpn is unknown.The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study as reported to customer relations: "lack of symptom relief resulting in 6 patients requiring a peg tube placement due to worsening dysphagia." 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.Of 85 patients included, 55 had malignant diseases while 30 patients benign conditions requiring sems placement.''for patients with obstructive dysphagia, given lack of quantifiable measure of symptom relief, subsequent placement of percutaneous feeding tube (peg)was used as the surrogate of ineffective sems placement.Of 65 patients who received esopheageal stent for the symptoms of dysphagia, there were 6 cases of lack of symptom relief requiring a peg tube placement due to worsening dysphagia.

Manufacturer Narrative

510(k) number cannot be provide as the rpn is unknown.The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.As reported to customer relations: "lack of symptom relief resulting in 6 patients requiring a peg tube placement due to worsening dysphagia." 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.Of 85 patients included, 55 had malignant diseases while 30 patients benign conditions requiring sems placement.''for patients with obstructive dysphagia, given lack of quantifiable measure of symptom relief, subsequent placement of percutaneous feeding tube (peg)was used as the surrogate of ineffective sems placement.Of 65 patients who received esopheageal stent for the symptoms of dysphagia, there were 6 cases of lack of symptom relief requiring a peg tube placement due to worsening dysphagia.

Event Description

Complaint received from internal personnel via e-mail on 20nov2019--did 20nov2019.Predictors of esophageal self-expandable metal stent migration: an academic center study.As reported to customer relations: "lack of symptom relief resulting in 6 patients requiring a peg tube placement due to worsening dysphagia." the choice of stent type (fully covered vs partially covered), brand (wallflex® [boston sci-entific], evolution [cook medical, (b)(4), usa], hanaro® [m.I.Tech, (b)(4)], and niti-s® (b)(4), and size was determined by the performing endoscopist.Of 85 patients included, 55 had malignant diseases while 30 patients benign conditions requiring sems placement.''for patients with obstructive dysphagia, given lack of quantifiable measure of symptom relief, subsequent placement of percutaneous feeding tube (peg)was used as the surrogate of ineffective sems placement.Of 65 patients who received esophageal stent for the symptoms of dysphagia, there were 6 cases of lack of symptom relief requiring a peg tube placement due to worsening dysphagia.

Manufacturer Narrative

Pma/510(k)#: k162717.Device evaluation: the evo (evolution esophageal metal stent ) device of unknown lot number was not returned to cook (b)(4) for evaluation.With the information provided, document based investigation was conducted.This file was created from the attached journal article to address "lack of symptom relief resulting in 6 patients requiring peg tube placement due to worsening dysphagia".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.A possible root cause could be attributed to patient condition related, as per instructions for use, food bolus impaction are listed as a complication following the placement of this device.As the device was not returned for evaluation and due to limited information available the cause of this complaint could not be conclusively determined.Summary: customer complaint is confirmed based on customer testimony.The patient outcome is unknown.However, we do know that the patients required prg tube placement as a result.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9416440
• MDR Text Key: 169273955
• Report Number: 3001845648-2019-00670
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention