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

Catalog Number EVO-FC-R-20-25-12-E

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The launching system remained attached to the stent.Lab evaluation date: 02 mar 2022.Visual inspection: lock wire is in place on return.Stent was fully deployed and still attached to the lock wire.Functional inspection: handle actuating as intended.Lock wire removed with no issues and stent detached from delivery system as intended.General questions: at what stage of the procedure did the complaint occur? during stent removal.What endoscope type and channel size was used? no endoscope stent evo-e.What was the position of the elevator? n/a.Details of the wire guide used (diameter, type, make)? was the zip port facing upwards and slightly curved when backloading the wire guide? n/a.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? n/a, please advise the anatomical location of the intended target site.Oesophage how long was the stent in the patient by the time this complaint occurred? for devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a.

Manufacturer Narrative

Device evaluation: the evo-fc-r-20-25-12-e device of lot number c1705620 involved in this complaint device was returned for evaluation opened and in its original packaging.With the information provided, a document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2022.On evaluation of the device the following was observed.Lab evaluation date: (b)(6) 2022 visual inspection: lock wire is in place on return.Stent was fully deployed and still attached to the lock wire.Functional inspection: handle actuating as intended.Lock wire removed with no issues and stent detached from delivery system as intended.Documents review including ifu review: prior to distribution all evo-fc-r-20-25-12-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-fc-r-20-25-12-e device of lot number c1705620 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot # c1705620; upon review of complaints this failure mode has not occurred previously with this lot # c1705620.The instructions for use ifu0067 which accompanies this device instructs the user to "when stent point -of -no return has been passed, pull and remove the safety wire completely out of the delivery handle near the wire guide port to allow full stent deployment." there is evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could be determined from the available information.A definitive root cause could be attributed to the user error, it was observed on return of the device the stent was fully deployed with the lock wire still attached.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

Manufacturer Narrative

Device evaluation: the evo-fc-r-20-25-12-e device of lot number c1705620 involved in this complaint device was returned for evaluation opened and in its original packaging.With the information provided, a document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 02nd march 2022 refer to attachments evo_lab evaluations attendance 02nd march 2022 for lab attendance.On evaluation of the device the following was observed.Lab evaluation date: 02 mar 2022.Visual inspection: lock wire is in place on return.Stent was fully deployed and still attached to the lock wire.Functional inspection: handle actuating as intended.Lock wire removed with no issues and stent detached from delivery system as intended.Documents review including ifu review: prior to distribution all evo-fc-r-20-25-12-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-fc-r-20-25-12-e device of lot number c1705620 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot # c1705620; upon review of complaints this failure mode has not occurred previously with this lot # c1705620.The instructions for use ifu0067 which accompanies this device instructs the user to "when stent point -of -no return has been passed, pull and remove the safety wire completely out of the delivery handle near the wire guide port to allow full stent deployment." there is evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.Root cause review: a definitive root cause could be determined from the available information.A definitive root cause could be attributed to the user error, it was observed on return of the device the stent was fully deployed with the lock wire still attached.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental correction follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.Below changes made: file was re-opened to update failure mode and annex c code from c13 to c23.

• 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: 13720472
• MDR Text Key: 289606084
• Report Number: 3001845648-2022-00129
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)220205(10)C1705620
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1705620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 02/10/2022; 02/10/2022
• Supplement Dates FDA Received: 10/20/2022; 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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