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 Structural Problem (2506); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure, the stent did not respond to the requested command.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation the evo-fc-r-20-25-12-e device of lot number c1647994 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Images were provided which show the stent fully deployed and detached from the device and an acute kink on the peek tubing.Prior to distribution 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 of lot number c1647994 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1647994.It should be noted that the instructions for use (ifu0067-2) states the following: "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is not sufficient evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.On review of the images provided the stent appears to be fully deployed and detached from the device and there is an acute kink on the peek tubing.A possible root cause could be attributed to the torturous path.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in an acute kink.This kink could have led to the stent getting stuck in the delivery system during the introducer withdrawal.From additional information provided: ¿4.Did any part of the product snag/get caught with the stent when removing the delivery system? yes, the stent was stuck in the delivery system¿ summary the complaint is confirmed based on customer 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.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12364201
• MDR Text Key: 269457527
• Report Number: 3001845648-2021-00622
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)210906(10)C1647994
• Combination Product (y/n): N
• 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
• Report Date: 03/03/2022

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: 09/06/2021
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1647994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• 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 Sex: Male