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 Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 yes related to oesophageal cancer (393854) (emdr # 3001845648-2023-00311).Tumour reduction therapy within 30 days procedure - chemo (393862) (emdr # 3001845648-2023-00286).Reason for study exit - stent migrated but not removed - supplemental fixation with clips.This file will capture user error of the customer using supplemental fixation with clips which did not contribute the stent migration reported.(410608 - current file).

Manufacturer Narrative

Supplemental report is being submitted as a cancellation report following the completion of the investigation as the complaint no longer meets the description of a reportable incident.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 was created in response to a pmcf study ¿user error ¿ supplemental fixation clip used during procedure¿ additional files listed were opened as a result of this study: pr 393854 mdr2054 201-013 ae1 gastrointestinal bleeding and dysphagia.Pr 393862 mdr2054 201-013 ae2 user error chemotherapy treatment after stent placement; migration/clips/bleeding/infection.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 ¿¿ the stent should only be placed with the cook delivery system, which is provided with each stent¿¿.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 ¿¿'the stent should only be placed with the cook delivery system, which is provided with each stent¿¿.It is known from the study that supplementation fixation clips were used during the procedure.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 supplementation fixation clips were used during the procedure.Confirmed quantity of 1 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.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 as a cancellation report following the completion of the investigation as the complaint no longer meets the description of a reportable incident.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.

• 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: 18065537
• MDR Text Key: 327287739
• Report Number: 3001845648-2023-00817
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/03/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 12/12/2023
• 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 Age: 48 YR
• Patient Sex: Male