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

Catalog Number EVO-FC-R-18-23-10-E

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

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Gastrointestinal other bleeding; device related; procedure not related, pre-existing no.Reason for study exit - stent migrated but not removed - supplemental clips placed.On day of placement gastrointestinal bleeding observed - bleeding secondary to stent insertion> resolved with adrenaline injection.Patient outcome : resolved, treatment endoscopic adrenaline injection for bleeding.

Manufacturer Narrative

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

Event Description

Supplemental follow-up correction report is being submitted due to the clinical input received on 9 may 2023.This event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 based on bleeding during the procedure and dysphagia requiring intervention/additional procedure.

Manufacturer Narrative

Device evaluation: the device evaluation for the v evo-fc-r-18-23-10-e of lot c1203519 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 ¿mdr2054¿ to capture ¿gastrointestinal bleeding¿ this file is related to pr (b)(4) which was opened to capture the user error of chemotherapy treatment after stent placement and subsequent stent migration.Manufacturing records.Prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c1203519 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label: the instructions for use, ifu0067 which accompanies this device, instructs the user that ¿¿ those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, fever ,haemorrhage, hypotension, infection, perforation, reflux , respiratory depression or arrest and vomiting.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 from the available information.A possible root cause could be attributed to known potential complications, as per the ifu, haemorrhage is a known potential complication associated 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 there was gastrointestinal bleeding secondary to stent insertion.Confirmed quantity of 1 device, confirmed used.According to the pmcf study, the bleeding was resolved by an adrenaline injection.Investigation findings conclude that a possible root cause could be attributed to patient condition.

Event Description

Supplement report being submitted due to the updates to the product details and completion of the investigation on 10-aug-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: 16852805
• MDR Text Key: 314393084
• Report Number: 3001845648-2023-00311
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551685
• UDI-Public: (01)10827002551685(17)180219(10)C1203519
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/10/2023

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 Expiration Date: 02/19/2018
• Device Catalogue Number: EVO-FC-R-18-23-10-E
• Device Lot Number: C1203519
• 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: 04/12/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 04/12/2023
• Supplement Dates FDA Received: 06/07/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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: 48 YR
• Patient Sex: Male