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

Catalog Number UNKNOWN

Device Problems Material Perforation (2205); Sharp Edges (4013)

Patient Problems Perforation (2001); Perforation of Esophagus (2399)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

510(k) number: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Factors that affect stent-related complications in patients with malignant obstruction of the esophagus or gastric cardia.Iwasaki et al.2017.Major complications occurred in 14 patients (26.4%), including four (7.5%) with perforation.Of the 4 cases perforation ''1 patient successfully treated with another stent inserted to close the rupture.'' three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment moc (b)(6) 2019.

Event Description

Factors that affect stent-related complications in patients with malignant obstruction of the esophagus or gastric cardia.Iwasaki et al.2017.Major complications occurred in 14 patients (26.4%), including four (7.5%) with perforation.Of the 4 cases perforation ''1 patient successfully treated with another stent inserted to close the rupture.'' three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).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.

Manufacturer Narrative

Pma/510(k)#: k162717.Device evaluation: the partially covered evolution stent device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document-based investigation was conducted.The literature review ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017 outlines major complications occurred in 14 patients (26.4%), including four (7.5%) with perforation of the 4 cases perforation.''1 patient successfully treated with another stent inserted to close the rupture,'' three types of stent were used in this literature review: partially or uncovered ultraflex stents (boston scientific), partially covered or uncovered niti-s stents (taewoong medical) and partially covered evolution stents (cook medical).We cannot confirm that the cook evolution stent was related to this this specific adverse event so this is a conservative assessment.This file is created to capture one case perforation successfully treated with another stent inserted to close the rupture lab evaluation: n/a.Documents review including ifu review: as the evo -pc- e device is from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo -pc- e 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, perforation is listed as a potential complication.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.

• 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: 9489512
• MDR Text Key: 174664819
• Report Number: 3001845648-2019-00742
• 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
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2016
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention