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

Catalog Number EVO-FC-R-18-23-10-E

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

Patient Problems Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Gastrointestinal dysphagia; device related, procedure not related, pre-existing yes related to oesophageal cancer tumour reduction therapy tihin 30 days procedure - chemo.Reason for study exit - stent migrated but not removed - supplemental fixation with clips.Ae 2 - 84 days post placement - gastrointestinal dysphagia due to migration stent into stomach - seen on ct.Patient outcome : resolved, treatment endoscopic new stent placed (non-study stent).

Manufacturer Narrative

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

Event Description

Supplemental correction report being submitted due to the updated assessment and annex coding gastrointestinal dysphagia; device related, procedure not related, pre-existing yes related to oesophageal cancer tumour reduction therapy within 30 days procedure - chemo reason for study exit - stent migrated but not removed - supplemental fixation with clips user error chemotherapy treatment provided after stent placement ae 2 - 84 days post placement - gastrointestinal dysphagia due to migration stent into stomach - seen on ct supplemental fixation with clips.

Manufacturer Narrative

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

Event Description

Supplemental correction report being submitted due to the updated to product details on (b)(6)2023.

Manufacturer Narrative

Device evaluation: user/use related complaints are 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.The device evaluation for evo-fc-r-18-23-10-e of lot c1203519 could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file is related to (b)(4) which was open to capture the user error of supplemental fixation clip during procedure and (b)(4) which captures the gastrointestinal bleeding.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1203519 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label : the instructions for use, ifu0067 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: definitive root cause was established.The user has not complied with the requirements of the ifu and/label.It is known from the available information that the patient received chemotherapy after stent placement.The instructions for use, ifu0067 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ it is possible the patient receiving chemotherapy contributed to the stent migration and it is known from the available information that the stent migration caused or contributed to the gastrointestinal dysphagia that was reported 84 days post stent placement.Confirmation of complaint : complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the pmcf study gastrointestinal dysphagia and stent migration was reported 84 days post stent placement.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient required a new stent to be placed as treatment for the stent migration to the stomach and subsequent dysphagia.Investigation findings conclude a definitive root cause was established.The user had not complied with the requirements of the ifu with respect to the intended use of the device.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 17-oct-2023.

• 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: 16852138
• MDR Text Key: 314376244
• Report Number: 3001845648-2023-00286
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551685
• UDI-Public: (01)10827002551685(17)180219(10)C1203519
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2023

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 Expiration Date: 02/19/2018
• Device Catalogue Number: EVO-FC-R-18-23-10-E
• Device Lot Number: C1203519
• 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: 04/12/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 04/12/2023; 04/12/2023
• Supplement Dates FDA Received: 05/31/2023; 09/06/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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: 48 YR
• Patient Sex: Male