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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Gastrointestinal- vomiting; 3 days post placement - developed vomiting resulting in endoscopic removal of study stent in which stent was seen to be migrated distally at endoscopy.New egis stent placed.Developed vomiting.Stent seen to be migrated distally at endoscopy.New egis stent placed.Resolved; treatment endoscopic - stent removed; death no.

Manufacturer Narrative

Device evaluation: the 1x evolution® esophageal controlled-release stent -fully covered device of unknown lot number and rpn involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to a pmcf study ¿mdr2054¿ to capture ¿vomiting and stent migration¿ the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: 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.Historical data review: historical data was not reviewed as the lot number is unknown.Instructions for use and/label review: as per the ifu (ifu0061), stent migration and vomiting are known potential adverse events associated with gi endoscopy "those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest, vomiting.Additional adverse events include, but are not limited to: airway compression, allergic reaction to nickel, retroesophageal fistula and retroesophageal fistula, chest or retrosternal pain, death (other than due to normal disease progression) dysphagia, edema, erosion or perforation of stent into adjacent vascular structures, esophageal ulceration and erosion, esophagitis, fistula involving trachea or bronchi or pleural space, food bolus impaction, foreign body sensation or reaction, gas bloat, inadequate stent expansion, intestinal obstruction secondary to migration, mediastinitis or peritonitis, nausea, pain/discomfort, reocclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction, tumour ingrowth or overgrowth, wire entrapment.¿ there is no evidence to suggest that the customer did not follow the instructions for use or product label.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 known procedural adverse events.As per the ifu, stent migration and vomiting are known potential adverse events associated with gi endoscopy.The adverse event of vomiting was deemed a cascading effect of the stent migration.As per the patient casebook, the patient¿s obstructive malignancy was also a contributing factor to the vomiting.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: as per the patient casebook, 3 days post-stent placement the patient presented with vomiting.When inspecting the patient endoscopically, the stent was noted as being distally migrated.The stent was removed endoscopically to treat the vomiting and migration experienced.Confirmed quantity of 01 used device.The investigation findings concluded a possible root cause of known procedural adverse events.Both vomiting and stent migration are known adverse events associated with gi endoscopy.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience an adverse effect due to this occurrence.The patient experiences vomiting caused by the stent migration.The patient required the study device to be removed endoscopically as treatment.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 the investigation on 09-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: 16867629
• MDR Text Key: 314544963
• Report Number: 3001845648-2023-00328
• 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: 11/09/2023

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: 12/07/2023
• 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: 56 YR
• Patient Sex: Male