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 Problems Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Gastrointestinal - dysphagia; device related, procedure not related, pre-existing yes- known scc oesophagus; device deficiency no.42 days post placement gastrointestinal dysphagia - tumour overgrowth of proximal end of stent - treated with endoscopic placement of new stent.Patient outcome: resolved; treatment- endoscopic new stent placed (non-study stent); no.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation the 1x evo-fc-r-20-25-12-e device of lot number c1349836 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 the pmcf study mdr-2054 to capture ¿dysphagia and tumour overgrowth¿.Lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Ifu & label review: as per the ifu (ifu0067), tumour overgrowth and dysphagia are known potential adverse event associated with upper gi endoscopy ¿additional adverse events 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, 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 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 review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to known procedural adverse events associated with the use of gi endoscopy on the patient.As per the ifu, both dysphagia and stent overgrowth are known potential adverse events associated with gi endoscopy.Summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.42 days post-placement a new (non-study) stent was placed to treat the tumour overgrowth.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted to correct typo error on rpn field on second tab of this mdr section d.Updating from g52226-evo-fc-20-25-12-e to g55172-evo-fc-r-20-25-12-e.No impact to other information in report previously submitted on 23 june-23.

Manufacturer Narrative

Supplemental follow-up report is being submitted to correct typo error on rpn field on second tab of this mdr section d.Updating from g52226-evo-fc-20-25-12-e to g55172-evo-fc-r-20-25-12-e.No impact to other information in report previously submitted on 23 june-23.

• 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: 16852678
• MDR Text Key: 314364977
• Report Number: 3001845648-2023-00309
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)190425(10)C1349836
• 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,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2019
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1349836
• 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: 04/25/2017
• 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: 70 YR
• Patient Sex: Male