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

Catalog Number EVO-FC-R-20-25-8-E

Device Problems No Apparent Adverse Event (3189); Migration (4003)

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

Event Type  Injury  

Event Description

Procedure: was the stent placed at the intended location at completion of the procedure? yes.Were any additional procedure (s) performed during the study procedure? no.Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.Adverse event: migration of the prosthesis to the stomach.Event category: gastrointestinal-control gastroscopy.Adverse event onset (days post stent placement): 7.Event treatment: study stent repositioned.Was the event considered to be related to the study device? related.If related, please provide a detail description of how study device caused or contributed to this event: migration of the prosthesis to the stomach.Was the event considered to be related to the study procedure? not related.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? no.Did the event occur due to a device deficiency? no.At the conclusion of follow-up what was the status of the study stent: stent removed endoscopically.Days post stent placement: 7.Reason for removal: other (unrelated to ae) when the stenosis disappeared, the prosthesis migrated to the stomach and was definitively removed because there was no longer a stenosis.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) #k162717.Device evaluation: the device evaluation for the evo-fc-r-20-25-8-e device of lot c1453573 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 ¿mdr2054¿ to capture ¿migration of the prosthesis to the stomach¿.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 c1453573 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 c1453573 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the instructions for use, ifu0067 which accompanies this device, states ¿additional complications that can occur in conjunction with biliary stent placement include, but are not limited to: trauma to the biliary tract or duodenum; perforation; obstruction of the pancreatic duct; stent migration; stent occlusion ; ingrowth due to tumour or excessive hyperplastic tissue; tumour overgrowth; stent misplacement, pain, fever ,nausea ,vomiting, inflammation, recurrent obstructive jaundice, bile duct laceration, detach( other that due to normal disease progression.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: no root cause determination is required as the complaint is not confirmed.It is known from the available information that the stent migration 7 days post placement was due to the disappearance of the stenosis and the stent was no longer required for the benign stricture.Confirmation of complaint: the complaint cannot be confirmed because the device or the procedure have not caused or contributed to the events reported.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 stent migrated to the stomach 7 days after placement.The study stent was removed endoscopically as it was no longer required.Confirmed quantity of 0 device, not confirmed the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that this complaint is not confirmed.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 05-sep-2023.

• 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: 15914583
• MDR Text Key: 304792101
• Report Number: 3001845648-2022-00830
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)200213(10)C1453573
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: 02/13/2020
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1453573
• 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: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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: 80 YR
• Patient Sex: Male