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); Obstruction/Occlusion (2422)

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

(b)(6): 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 may 25, the stent was lifted a little higher by gastroscopy.The patient had persistent severe pain and nausea as a result of stent placement.(b)(6): user error: patient treated with chemotherapy (as per ifu: after stent placement alternative methods of treatment such as chemotherapy should not be administered).On june 2, 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.(b)(6): 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.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.Ple.

Manufacturer Narrative

Pma/510(k) # k162717.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.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.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.Instructions for use and/label: the instructions for use, ifu0061 which accompanies this device, instructs the user: ¿¿ to reposition stent directly after placement, grip the white lasso at proximal- end lasso or the distal end lasso with forceps and reposition stent to desired area¿¿ and ¿¿ additional complications include, but are not limited to: stent misplacement and/or migration; tumour ingrowth or overgrowth , pain and nausea¿¿ 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 with respect to the intended use of the device.It is known from the available information that the stent was repositioned by gastroscopy after its initial placement.The repositioning of the stent would have most likely contributed to the pain and nausea experienced by the patient.The stent obstruction observed is a known potential complication of using evolution esophageal stents.The safety wire breakage( lasso loop) reported was most likely caused by the extra force that would been required during the attempted removal of the stent.The user error of attempting to remove the device was captured in pr (b)(4)/ mdr#3001845648-2022-00486.It may be noted as the stent was placed on the 04th may 2022 the safety wire would not be present on the 24th may 2022.Therefore '' the safety wire is broken '' it likely the customer referring to the lasso loop.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.According to the initial report the patient is in a hard physical and emotional condition.Investigation findings conclude that the user has not complied with the requirements of the ifu with respect to the intended use of the device.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 10-aug-2023.

• 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: 15121139
• MDR Text Key: 296770543
• Report Number: 3001845648-2022-00484
• 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: 08/10/2023

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: 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: 06/29/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 09/07/2023
• 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