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

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Gastrointestinal dysphagia; device related; procedure not related; pre-existing no; dilation to 12 mm peformed during placement procedure.Ae 1 - 147 dayspost placement gastroentestinal dysphagia requiring endoscopic dilation to manage.Stent irritation or reflux likely led to inflammatory stricture formation needing endoscopic management.

Event Description

This correction follow-up report is being submitted due to below updates made to the complaint record on 05-may-2023: 1.User error identified as physician/assistant performed alternative treatment method post placement of stent - chemotherapy treatment after stent placement.2.Section 10.Medical device problem code (annex a) changed from a24 - adverse event without identified device or use problem to a2303 - improper or incorrect procedure or method.3.Section 10.Component code (annex g) changed from g04122 - stent to g07001 - part/component/sub-assembly term not applicable.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 07-sep-2023.

Manufacturer Narrative

Device evaluation: the 01x evolution esophageal device of unknown rpn and lot involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to a pmcf study ¿(b)(4)¿ to capture ae1 - user error for administering alternative treatment (chemotherapy) post-placement of the stent as well as dysphagia.The following were also raised in response to this pmcf study: (b)(4) (emdr 3001845648-2023-00288) (b)(4) ae2 user error chemotherapy treatment after stent placement and gastrointestinal dysphagia.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.User/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Manufacturing records review: manufacturing records review could not be completed as the lot number is unknown.Instructions for use and/label review: as per the ifu (ifu0061), dysphagia is a known potential adverse event associated with gi endoscopy ¿additional adverse events include, but are not limited to: airway compression, allergic reaction to nickel, retroesophageal fistula and retroesophageal fistula, chest or retrosternal pain, death (other than due to normal disease progression) dysphagia, edema, erosion or perforation of stent into adjacent vascular structures, esophageal ulceration and erosion, esophagitis, fistula involving trachea or bronchi or pleural space, food bolus impaction, foreign body sensation or reaction, gas bloat, inadequate stent expansion, intestinal obstruction secondary to migration, mediastinitis or peritonitis, nausea, pain/discomfort, reocclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction, tumour ingrowth or overgrowth, wire entrapment¿ there is evidence to suggest that the customer did not follow the instructions for use/product label.It should be noted that the instructions for use (ifu0061) states the following: ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase the risk of stent migration due to tumour shrinkage, stent erosion and/or mucosal bleeding¿.As the patient received chemotherapy during follow-up, this complaint has been deemed use error.Furthermore, the use of chemotherapy was deemed an attributing factor to the dysphagia documented in ae#1 of the patient casebook.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of use error was identified from the available information.Since the patient received follow-up treatment after being implanted with the evolution esophageal stent, this in turn caused the irritation or reflux that led to the inflammatory stricture reported in the casebook.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01 used device.Summary of investigation: according to the initial reporter, the patient did experience an adverse effect due to this occurrence.The patient presented with dysphagia which was deemed related to the stent irritation or reflux leading to an inflammatory stricture.The patient required endoscopic dilation to manage the occurrence.The patients outcome was resolved.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16867627
• MDR Text Key: 314544499
• Report Number: 3001845648-2023-00327
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 04/11/2023; 04/11/2023
• Supplement Dates FDA Received: 06/02/2023; 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female