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

Model Number G48030

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Pain (1994)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k162717.The investigation is in progress and a follow up mdr will be submitted.

Event Description

Pr (b)(4): stent obstruction and safety wire breakage resulting in pain and nausea.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.Pr (b)(4): user error - 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.Pr (b)(4): user error - 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.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.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.On (b)(6) 2022, a stent was placed in the patient's esophagus due to dysphagia.On (b)(6), 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.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.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.

Manufacturer Narrative

Pma/510(k) # k162717.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 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) (emdr ref.-3001845648-2022-00484) and (b)(4) (emdr ref.-3001845648-2022-00486).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 c1906670 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label.The instructions for use which accompanies this device, states ¿'after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered at this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding¿'& ''additional complications include, but are not limited to: tumour ingrowth or over growth.'' there is evidence to suggest that the customer did not follow the instructions for use.Therefore additional complaint file was raised pr 396285 to capture the use of the incorrect wire guide.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.According to the information available the patient was treated with chemotherapy after stent placement.Summary of investigation.According to the customer the patient was treated with chemotherapy post stent placement.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient is in a hard physical and emotional condition.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.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

• 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: 15121138
• MDR Text Key: 296769050
• Report Number: 3001845648-2022-00485
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: G48030
• Device Catalogue Number: EVO-20-25-8-E
• Device Lot Number: C1906670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 06/09/2023
• 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 Sex: Female