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 Off-Label Use (1494); Migration (4003)

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

Event Type  Injury  

Event Description

(b)(6) - device issues: stent migration.Device issue: not related.Device deficiency: no.(b)(6) - 30 days post placement: distal stent migration to distal jejuno confirmed by endoscopy.(b)(6) - 95 days post procedure: stent misplacement in the pelvic area.Event status: event ongoing.Treatment: no.Death: no.

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.This file was created from pmcf study.This file is related to (b)(4) (emdr 3001845648-2023-00312).Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all evolution esophageal controlled-release stent - fully covered devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for evo-fc-r-20-25-8-e of lot number c1568003 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: n/a.Instructions for use and/label: it should be noted that the instructions for use (ifu0067) states the following: "this device is used to maintain luminal patency of the esophagus in cases of: obstruction caused by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas." there is evidence to suggest the user did not follow the ifu or label.As per case study this device was used for "dehiscence of the esophageal-jejunal anastomosis." image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of off label use can be concluded based on the information provided.The information for use states that the device is intended for use to maintain luminal patency of the esophagus in cases of: obstruction caused by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas.However from the information provided the device was used for treatment of an anastomosis , this is considered off label use.The off label use may have caused and/or contributed to the adverse event of stent migration as it is unknown how the device will perform outside of its intended use.It should also be noted that stent migration is listed as a potential adverse event in the ifu.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, device issues: stent migration.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, patients outcome was unknown.Event status: event ongoing, treatment: no, death: no.Investigation findings conclude that a definitive root cause of off label use can be concluded based on the information provided.Complaint is confirmed based on customer and/or rep testimony.

Event Description

This supplemental report is being submitted due to completion of the investigation on the 02-nov-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: 16852618
• MDR Text Key: 314387101
• Report Number: 3001845648-2023-00307
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)201217(10)C1568003
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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: 12/17/2020
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1568003
• 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: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• 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 Sex: Male