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

Catalog Number EVO-20-25-8-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stent obstruction and safety wire breakage resulting in pain and nausea + user error: stent repositioning.On (b)(6) 2022, a stent was placed in the patient's esophagus due to dysphagia.On (b)(6) , a month later, it turned out that the mucosa of the esophagus was overgrown with a stent from both ends.And the safety wire is broken.It became impossible to remove a stent.Pet-ct showed that the lumen of the stent was obstructed, so on (b)(6), the stent was lifted a little higher by gastroscopy.The patient had persistent severe pain and nausea as a result of stent placement.User error: patient treated with chemotherapy (as per ifu: after stent placement alternative methods of treatment such as chemotherapy should not be administered).On (b)(6) 2022, the patient began a weekly course of chemotherapy with paclitaxel and carboplatin.In about 10 days after the start of chemotherapy, the pressure/pain and nausea went away, but for the last 10 days the patient started to feel pain and difficulty at swallowing, so a chest ct was done, which showed that the oncological nodules had shrunk and pressure on the esophagus has been lifted, although it turned out that the mucosa of the esophagus was overgrown with a stent from both ends.User error: attempted removal of device (as per ifu: this stent is not intended to be removed and is intended to remain in the body permanently).A plan was developed to remove the stent by gastroscopy, but it turned out that the mucosa of the esophagus was overgrown with a stent from both ends.The threads at the ends of the stent were torn.It became impossible to remove the stent (they tried to remove the stent twice but neither tries were successful).As there is no solution to this issue, the oncologist temporarily suspended chemotherapy, because we do not know what type of intervention will be necessary, and due to the recent interventions, the patient had fever, irritation of respiratory tract, nausea, difficulty swallowing and pain in the stent/esophagus area.The patient is in a hard physical and emotional condition.Due to the complication with stent vitally important for her chemotherapy was stopped.Stent removal is the most important on this stage.This file will capture the stent obstruction observed.It is impossible to remove the stent, that esophageal mucosa is stuck in uncovered sites of the stent.The threads at the ends of the stent are torn.The patient is in a hard physical and emotional condition.Due to the complication with stent vitally important for him chemotherapy was stopped.Please share your experience how this problem can be solved, what ways you recommend to remove the stent.A plan was developed to remove the stent by gastroscopy, but it turned out that the mucosa of the esophagus was overgrown with a stent from both ends.The threads at the ends of the stent were torn.It became impossible to remove the stent (they tried to remove the stent twice but neither tries were successful).As there is no solution to this issue, the oncologist temporarily suspended chemotherapy, because we do not know what type of intervention will be necessary, and due to the recent interventions, the patient had fever, irritation of respiratory tract, nausea, difficulty swallowing and pain in the stent/esophagus area.The patient is in a hard physical and emotional condition.Due to the complication with stent vitally important for her chemotherapy was stopped.Stent removal is the most important on this stage.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 30-nov-2023.

Manufacturer Narrative

Pma/510(k) #k162717.Device evaluation: the device evaluation evo-20-25-8-eof lot c1906670 could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file is related to pr 368137, emdr 3001845648-2022-00484 (stent obstruction and safety wire breakage resulting in pain and nausea), pr 369524, emdr 3001845648-2022-00485(user error: patient treated with chemotherapy) and pr 369526, emdr 3001845648-2022-00486 (user error: attempted removal of device).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 number c1906670 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1906670 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label : the instructions for use, ifu0061 which accompanies this device, instructs the user: ¿¿ additional complications include, but are not limited to: stent misplacement and/or migration; tumour ingrowth or overgrowth; oesophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus.¿¿ there is no 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 could not be established.A possible root cause could be attributed to patient condition related, as per instructions for use, tumour ingrowth or overgrowth is listed as a complication following the use of this device.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 customer the stent was obstructed which led them to repositioning the stent.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.The patient is in a hard physical and emotional condition after the repositioning , chemotherapy and attempted removal of the stent.Investigation findings conclude that a possible root cause could be attributed to patient condition related.

• 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
• 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: 17486562
• MDR Text Key: 320664494
• Report Number: 3001845648-2023-00605
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480305
• UDI-Public: (01)10827002480305(17)240124(10)C1906670
• Combination Product (y/n): N
• Reporter Country Code: GG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Catalogue Number: EVO-20-25-8-E
• Device Lot Number: C1906670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2022
• Event Location: Hospital
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: 37 YR
• Patient Sex: Female