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

Model Number G48032

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k162717.The investigation is in progress and a follow up mdr will be submitted.

Event Description

The stent came out with the delivery system , even after successful deployment.

Manufacturer Narrative

Pma/510(k) #k162717.The investigation is in progress and a follow up mdr will be submitted.

Event Description

Supplemental report is being submitted due to the completion of a lab evaluation.

Manufacturer Narrative

Pma/510(k) #k162717.The evo-20-25-12.5-e device of lot number c1800002 involved in this complaint was returned for evaluation, with its original packaging.With the information provided, a physical examination and document based investigation was conducted.The device involved in the complaint was evaluated in the laboratory.In summary the following results were observed in the lab evaluation: stent and lock wire were detached and returned separately.Red marker at the end of the deployment system on return.Handle actuated as intended.Prior to distribution all evo-20-25-12.5-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-20-25-12.5-e device of lot number c1800002 did not reveal any discrepancies that could have contributed to this issue.The instructions for use which accompanies this device instructs the user to "when stent point-of-no return has passed, pull safety wire out of delivery handle near wire guide port", "after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed.".There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.There may be many possible root causes for the issue encountered, some may include the following: a possible root cause could be attributed to the difficult target site which could lead to a stent getting caught up on the delivery system tip, user technique or the suture getting caught up on the bi-lumen causing issue reported.According to the initial reporter, the patient did not require any additional procedures due to this occurrence.Customer complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• 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 ; 061334440
• MDR Report Key: 13423408
• MDR Text Key: 287254202
• Report Number: 3001845648-2022-00050
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)230210(10)C1800002
• 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: 09/16/2022

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: 02/10/2023
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1800002
• 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: 01/05/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 01/06/2022; 01/06/2022
• Supplement Dates FDA Received: 03/29/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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: 71 YR
• Patient Sex: Male