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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Failure of Implant (1924); Occlusion (1984); Obstruction/Occlusion (2422)

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

Title of literature review: ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017.'' stent migration to the distal portion was found at the time of the endoscopy, and another stent was placed for proximal stenosis.¿¿ 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.Stent migration to the distal portion was found at endoscopy and managed by placing another stent.

Manufacturer Narrative

Pma/510(k)#: k162717.The evo (evolution esophageal controlled-release stent - partially covered) 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 article to address: "1 case stent migration managed by placing another stent." 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.As the evo partially -covered esophageal stent is unknown device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo- (partially-covered esophageal 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, which informs the user about the potential complications "additional complications include, but are not limited to: stent misplacement and/or migration." on review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.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.Customer complaint is confirmed based on customer testimony.The patient suffered stent migration resulting in another stent placement.Complaints of this nature will continue to be monitored for potential emerging trends.Attachment: [iwasaki 2017.Pdf].

Event Description

Title of literature review: ''factors that affect stent -related complications in patients with malignant obstruction of the esophagus or gastric cardia'' iwasaki et al 2017.'' stent migration to the distal portion was found at the time of the endoscopy, and another stent was placed for proximal stenosis¿¿ 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.Stent migration to the distal portion was found at endoscopy and managed by placing another stent.

• 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: 9482002
• MDR Text Key: 188117087
• Report Number: 3001845648-2019-00736
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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