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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)

Event Type  Injury  

Event Description

Gastrointestinal other haematemesis; device related, procedure, not related, pre-existing yes oesophageal cancer and stent.Patient outcome: resolved; treatment endoscopic - no option had urgent upper gi endoscopy.No therapy + blood transfusion.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: the device evaluation for the evolution® esophageal controlled-release stent -fully covered of unknown lot number could not be complete as the device or photographic evidence of the device was not returned for evaluation.This file was created in response to a pmcf study ¿(b)(4)¿ to capture ¿gastrointestinal haematemesis -stent induced bleeding at distal end -requiring endoscopic treatment¿.This file is related to (b)(4) cardiac arrhythmia stent - upper gi bleed - anaemia - intermittent 2 degree heart block¿.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/label.The instructions for use, ifu0061 which accompanies this device, instructs the user that ¿¿ those associated with upper gi endoscopy include, but are not limited to; perforation, haemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.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: a definitive root cause could not be determined.A possible root cause could be attributed to patient pre-existing conditions.It is known from the available information that the patient had oesophageal cancer.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the pmcf study the patient experience stent induced bleeding at the distal end.Confirmed quantity of (b)(4) device, confirmed used.According to the pmcf study, the patient received a blood transfusion due to the bleeding.It is known from the available information the patient cause of death was oesophageal cancer.Investigation findings conclude that a possible root cause could be attributed to patient condition.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 30-nov-2023.

• 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: 16852580
• MDR Text Key: 314368629
• Report Number: 3001845648-2023-00305
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 04/11/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 90 YR
• Patient Sex: Male