MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

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

Patient Problems Aspiration/Inhalation (1725); Pulmonary Dysfunction (2019); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

K162717 - us clearance number cannot be confirmed as we don't have the exact rpn.This is the most likely us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

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 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).3 cases pulmonary complications.2 of which were pneumonia aspiration (after 3 days insertion).1 case symptomatic tracheal compression directly after esophageal stent insertion - managed by placing a tracheal stent.''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.

Manufacturer Narrative

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 specific adverse event so this is a conservative assessment this file captures 3 cases pulmonary complications.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.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Summary: complaint is confirmed based on customer testimony.Patient outcome is unknown.However we do know intervention was required.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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 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).3 cases pulmonary complications.2 of which were pneumonia aspiration (after 3 days insertion).1 case symptomatic tracheal compression directly after esophageal stent insertion - managed by placing a tracheal stent.''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.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9494131
• MDR Text Key: 188900121
• Report Number: 3001845648-2019-00753
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention