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 Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4).Radiation , chemotherapy and surgery performed to reduce tumour 30 days prior to placement patient received chemotherapy and radiation after stent placement.Stent removed endoscopically 30 days post placement as stent no longer required.10 days post placement - device issue of extravasation of contrast through the endoprosthesis noted - no treatment carried out.Correctly placed esophageal prosthesis in the distal third that does not cover the entire upper cup of the esophageal circumference due to post-surgical problem due to small invagination of the jejunal loop with passage to the distal jejunum with slight pressure this complaint will capture the 1 x case of user error for the patient receiving chemo & radiation after stent placement.Patient outcome: event: resolved ( patient recovered / stabilized), treatment: no treatment, death: no.

Event Description

Correction report is being submitted due to the cancellation of this file (b)(4) as use error will now be captured in (b)(4) (manufacture reference number: 3001845648-2023-00316).

Manufacturer Narrative

Pma/510(k)#: k162717.Correction report is being submitted due to the cancellation of this file (b)(4) as use error will now be captured in (b)(4) (manufacture reference number 3001845648-2023-00316).

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 17048934
• MDR Text Key: 316419615
• Report Number: 3001845648-2023-00432
• Device Sequence Number: 1
• Product Code: ESW
• 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: 01/18/2024

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: 07/07/2022
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1742025
• 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: 05/08/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG