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 Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Airway Obstruction (1699)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Respiratory, thoracic, mediastinal; airway compression; device related, procedure not related, pre-existing no.Deficiency no.Reason for placement - benign stricture.On day of placement - respiratory, thoracic, mediastinal - airway compression.Tracheal compression with stent, so tracheal stent placed.Was planned joint procedure in case.Patient outcome: resolves, treatment endoscopic new stent placed (non-study stent) of this eventuality.

Manufacturer Narrative

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

Event Description

Supplemental follow-up mdr correction report is being submitted due to product manager input received on 09 may 2023 confirming off-label use.

Event Description

Supplemental follow-up mdr correction report is being submitted due updates made to product details and removal of off label assessment on (b)(6) 2023.

Manufacturer Narrative

Pma 510k # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

This file was created from pmcf study to capture respiratory, thoracic, mediastinal; airway compression.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution, all evo-fc-r-18-23-10-e devices are subjected to functional checks and visual inspection to ensure device integrity.It may be noted that there has been discrepancies in rpn number provided.(pr 393719_rpn needs to be updated.Msg).Review historical data: n/a.Instructions for use and/label: it should be noted that the instructions for use (ifu0067) which informs the user about the potential complications "additional complications include, but are not limited to: airway compression, allergic reaction to nickel, aortoesophageal fistula and arterioesophageal 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, 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, tumor overgrowth, wire entrapment.As per medical advisor ¿respiratory, thoracic, mediastinal¿ is an event category.¿airway compression¿ fits one of the category ¿respiratory¿, ¿airway compression¿ is the only ae that is covered in the pae section of the ifu0067-3.".There is no evidence to suggest the user did not follow the ifu or 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 patient condition related, as per instructions for use, airway compression is listed as a potential complication.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 customer, respiratory, thoracic, mediastinal; airway compression.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, resolves, treatment endoscopic new stent placed (non-study stent).Investigation findings conclude that a possible root cause could be attributed to patient condition related, as per instructions for use, airway compression is listed as a potential complication.Complaint is confirmed based on customer and/or rep testimony.

Event Description

This supplemental report is being submitted due to completion of the investigation on the 02-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: 16852648
• MDR Text Key: 314381255
• Report Number: 3001845648-2023-00308
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551685
• UDI-Public: (01)10827002551685(17)181122(10)C1297994
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 11/02/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/22/2018
• Device Catalogue Number: EVO-FC-R-18-23-10-E
• Device Lot Number: C1297994
• 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; 04/11/2023; 04/11/2023
• Supplement Dates FDA Received: 06/07/2023; 08/31/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• 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: 63 YR
• Patient Sex: Female