MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G48033
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Event or Problem Description
(b)(4) - gastrointestinal: stent dislocation distal, relationship: device , related ; stent dislocation needs to reposition, procedure: non related, pre-existing,: no , deficiency: no.2 days post procedure.Stent dislocation distal - stent repositioned endoscopically.(b)(4).This file will capture the user error chemotherapy after stent placement (b)(4).Patient outcome: status: resolved, treatment: endoscopic, study stent repositioned, death: no.
Additional Manufacturer Narrative
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 for evo-20-25-15-e of lot c1633088 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 created in response to a pmcf study ¿(b)(6)¿ to capture ¿gastrointestinal: other; stent dislocation distal¿.This file (b)(4) will capture the user error chemotherapy after stent placement.Additional file is required as the chemotherapy received by the patient unlikely contributed to the stent migration which occurred 2 days post procedure.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 c1633088 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, 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.As per instructions for use 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.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 the patient received chemotherapy post stent placement.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.The study stent was repositioned.The chemotherapy received by the patient unlikely contributed to the stent migration which occurred 2 days post procedure.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu and/label.
Event or Problem Description
This supplemental report is being submitted due to the completion of the investigation on the 06-jul-2023.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• 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: 17096986
• Report Number: 3001845648-2023-00456
• Device Sequence Number: 11440855
• Product Code: FGE
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)210719(10)C1633088
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1633088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 72 KG