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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Distal stent migration to stomach confirmed by endoscopy.On day of placement - dilation to 11mm and supplemental fixation with 4 clips.14 days post placement stent migration distally to stomach requiring endoscopic repositioning.Resolved; treatment - endoscopic study stent repositioned; death no;.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: the device evaluation of the evolution® esophageal controlled-release stent -fully covered could not be completed 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 ¿stent migration confirmed with endoscopy¿ 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, states ¿additional complications that can occur in conjunction with upper gi endoscopy include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or over growth; oesophageal ulceration and erosion; nausea chest or retrosternal pain; foreign body sensation ;food bolus impaction; gas bloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction; aorta and arterioesphageal fistula; erosion or perforation of stent into adjacent vascular structures.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Therefore additional complaint file (b)(4) was raised which captures the user error of using supplementation fixation clips during stent placement.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition, as per instructions for use, stent migration is listed as a potential complication that can occur in conjunction with upper gi endoscopy.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 14 days post placement stent migrated distally to stomach.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.The study stent was repositioned.Investigation findings conclude a definitive root cause was established.A possible root cause could be attributed to patient condition.

Event Description

A supplemental report is being submitted due to completion of the investigation on the 27-oct-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: 16867630
• MDR Text Key: 314543334
• Report Number: 3001845648-2023-00326
• 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: 10/27/2023

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?: Yes
• 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: 05/04/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 57 KG