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

Model Number G48032

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As per physician "while using product, after 50% deployment whenever dr start remove safty wire its got stucked and after that stent comes out with delivery system and same stent not deployed.Dr using our another esophagial sems and complete the procedure¿.

Manufacturer Narrative

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

Event Description

Supplemental follow-up report is being submitted due to the evaluation of the complaint device on 28-feb-2023.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 13-sep-2023.

Manufacturer Narrative

Pma/510(k) # k162717 device evaluation the device evaluation evo-20-25-12.5-e of lot c1934633 was complete on 28th feb 2023.On evaluation of the device the safety tab was not returned.The safety wire was slightly removed but still in place.Directional button was in the deploy position on return.Red marker was at the 22nd dimple.Stent returned deployed and attached to the safety wire.Handle was actuating fine for deployment and recapture.Safety wire removed with no issue.Stent released with no issue and intact.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 c1934633 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 c1934633 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0061 which accompanies this device, instructs the user: ¿¿ when the stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port.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 definitive root cause could not be determined.A possible root cause could be attributed to difficult patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure which may have led to the safety wire getting caught on the stent and subsequently causing stent deployment difficulties.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/ correction complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer the safety wire got stuck and the stent would not deploy.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.Investigation findings a possible root cause could be attributed to difficult patient anatomy.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY 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: 16434648
• MDR Text Key: 310272038
• Report Number: 3001845648-2023-00129
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2023

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: 04/20/2024
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1934633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 01/30/2023; 01/30/2023
• Supplement Dates FDA Received: 03/29/2023; 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 50 KG