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

Catalog Number EVO-FC-R-20-25-12-E

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

Patient Problem Pneumonia (2011)

Event Type  Injury  

Event Description

Mdr2054 201-014 ae1.Respiratory, thoracic, mediastinal pneumonia; device related, procedure not related, pre-existing no.Tumour reduction therapy witihin 30 days prior procedure - chemo.Ae 1 - 1 day post placement- respiratory, thoracic, mediastinal - pneumonia - medical intervention - post stent insertion aspiration or hapae.Resolved; medical abc; no.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional report is being submitted due to additional information being received on the 29-aug-23 which updated the rpn from evo-fc-20-25-12-e to evo-fc-r-20-25-10-e.

Manufacturer Narrative

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

Event Description

Supplemental correction mdr report being submitted due to updated form received with rpn corrected on 18-sep-2023.Correction to rpn from evo-fc-20-25-12-e to evo-fc-r-20-25-10-e was completed in previous correction report, this report corrects the rpn in section d of the report.

Event Description

This supplemental report is being submitted to include the investigation conclusions complete on 03-nov-2023.

Manufacturer Narrative

This file was created from pmcf study to capture pneumonia.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-20-25-12-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.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 "those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, fever, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest, vomiting.As per medical advisor ¿ifu: aspiration; infection." 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, aspiration and infection are 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 - pneumonia.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, resolved, treatment medical abc, no.As per medial advisors input "medical intervention s=4" investigation findings conclude that a possible root cause could be attributed to patient condition related, as per instructions for use, aspiration and infection are listed as a potential complication.Complaint is confirmed based on customer and/or rep testimony.

Event Description

This supplemental correction report is being submitted to update the rpn to (b)(4).

Manufacturer Narrative

This file was created from pmcf study to capture pneumonia.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-20-25-12-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.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 "those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, fever, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest, vomiting.As per medical advisor ¿ifu: aspiration; infection." 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, aspiration and infection are 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 - pneumonia.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, resolved, treatment medical abc, no.As per medial advisors input "medical intervention s=4".Investigation findings conclude that a possible root cause could be attributed to patient condition related, as per instructions for use, aspiration and infection are listed as a potential complication.Complaint is confirmed based on customer and/or rep testimony.

• 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: 17188910
• MDR Text Key: 317728769
• Report Number: 3001845648-2023-00497
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)190531(10)C1361876
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1361876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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: 68 YR
• Patient Sex: Male