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

Catalog Number EVO-FC-R-20-25-8-E

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problems Abdominal Pain (1685); Pain (1994); Dysphasia (2195); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mdr- 2054 - 301-019 - ae1.Abdominal pain and he presented respiratory deterioration with dyspnoea, desaturation and a gastroscopy was performed, showing leak from the anastomosis endoscopy confirmed distal stent migration - partially covering lesion but remains in esophagus.Endoscopic intervention - study stent repositioned.Patient outcome : event status: resolved ( patient recovered / stabilized), treatment: endoscopic, study stent repositioned, death: no.Patient death - 113 days post placement - acute respiratory failure and stage iv tumor progression - not related to stent.

Event Description

Supplemental report is being submitted due to medical affairs confirms off label contributed to migration received on 28-jul-2023.

Manufacturer Narrative

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

Event Description

A supplemental report is being submitted due to completion of the investigation on the 26-oct-2023.

Manufacturer Narrative

Device evaluation: the 1x evo-fc-r-20-25-8-e device of lot number c1629230 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 ¿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.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label review: as per the ifu (ifu0067), stent migration is a known potential adverse event associated with 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.¿ upon reviewing the complaint detail/events provided in the patient casebook, it was noted that the device was used against the intended use outlined in the ifu.As per the ifu, the intended use is listed as ¿this device is used to maintain luminal patency of the esophagus in cases of: obstruction caused by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas¿ while the complaint device was used to treat ¿post-surgical dehiscence in esophageal-jejunal anastomosis¿ image review : an image was not returned for evaluation.Root cause analysis: a definitive root cause of off-label use was identified from the available information.The evo-fc-r-20-25-8-e device involved in this complaint was used for the treatment of ¿post-surgical dehiscence in esophageal-jejunal anastomosis¿, which is a contradiction to the intended use of the ifu (ifu0067).The stent migration reported in the patient casebook was deemed a cascading effect of the off-label use off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: as per the patient casebook, 50 days post stent placement the patient presented with abdominal pain and respiratory deterioration with distal stent migration, both the pain and respiratory deterioration were deemed side effects of the stent migration.The migration was treated by repositioning the study stent endoscopically.Confirmed quantity of 01 used device.The investigation findings concluded a definitive root cause of off -label use for using an evo-fc-r-20-25-8-e device for the treatment of ¿post-surgical dehiscence in esophageal-jejunal anastomosis¿, with the reported stent migration being deemed a cascading effect of the off-label use.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient presented with abdominal pain and respiratory deterioration with distal stent migration.After stent repositioning the patient recovered/stabilised.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 16852391
• MDR Text Key: 314370165
• Report Number: 3001845648-2023-00301
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)210708(10)C1629230
• 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: 10/26/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1629230
• 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: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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
• Patient Weight: 79 KG