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 Perforation (2001); Ulcer (2274); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

(b)(4) - device issues: other device issues; extravasation of contrast through the endoprosthesis, relationship, device, not related, procedure, related, pre-existing; yes, deficiency: no.Radiation , chemotherapy and surgery performed to reduce tumour 30 days prior to placement.Patient received chemotherapy and radiation after stent placement.Stent removed endoscopically 30 days post placement as stent no longer required.10 days post placement - device issue of extravasation of contrast through the endoprosthesis noted - no treatment carried out.Correctly placed esophageal prosthesis in the distal third that does not cover the entire upper cup of the esophageal circumference due to post-surgical problem due to small invagination of the jejunal loop with passage to the distal jejunum with slight pressure.Event: resolved ( patient recovered / stabilized), treatment: no treatment, death: no.

Manufacturer Narrative

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

This correction supplemental report is being submitted to capture the off-label usage of placement of the evolution stent, 'the physician placed the stent in order to alleviate/treat ¿dehiscence of the post-surgery anastomosis¿', confirmed on (b)(6) 2023.As a result section 10.Medical device problem code (annex a) is updated from (b)(6) - migration to (b)(6) - off-label use.

Manufacturer Narrative

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

Event Description

This correction supplemental report is being submitted to capture the correction of the use error present in file (b)(4), to now be captured in current file (b)(4) on 17-jan-2024.As a result annex e is updated from e2403 - no clinical signs, symptoms or conditions to e2339 - ulcer and e2114 - perforation.And annex f is updated from f26 - no health consequences or impact to f23 - unexpected medical intervention.Mdr- 2054 301-033 ae1 - device issues: other device issues; extravasation of contrast through the endoprosthesis, relationship, device, not related, procedure, related, pre-existing; yes, deficiency: no.Radiation , chemotherapy and surgery performed to reduce tumour 30 days prior to placement.Patient received chemotherapy and radiation after stent placement.Stent removed endoscopically 30 days post placement as stent no longer required.10 days post placement - device issue of extravasation of contrast through the endoprosthesis noted - no treatment carried out.Correctly placed esophageal prosthesis in the distal third that does not cover the entire upper cup of the esophageal circumference due to post-surgical problem due to small invagination of the jejunal loop with passage to the distal jejunum with slight pressure.

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation: the 1x evo-fc-r-20-25-8-e device of lot number c1742025 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 both off label use and use error¿.A related file, (b)(4), was raised and subsequently cancelled.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: upon reviewing the complaint detail provided in the patient casebook, it was noted that the device was used against the intended use outlined in the ifu (ifu0067).As per the ifu, the intended use is listed as ¿this device is used to maintain liminal 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 ¿dehiscence of the post-surgery anastomosis¿.The use of the evo-fc-r-20-25-8-e device for this treatment was deemed off label use as it is not covered within the outlined intended use of the device.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.Furthermore, as per the ifu, ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase the risk of stent migration due to tumour shrinkage, stent erosion and/or mucosal bleeding¿, it is known that post-stent placement the patient received chemotherapy and therefore deems this complaint use-error secondary to off-label (ref att.¿mdr2054_pat_301-033_2023_04_03_09_06.Pdf - pr 393676.Pdf¿).Image review : an image was not returned for evaluation.Root cause analysis: a definitive root cause of off label use and use error were identified from the available information.The complaint device was used for the treatment of ¿dehiscence of the post-surgery anastomosis¿ which was deemed a contradiction of the intended use of the device.Furthermore, the patient received chemotherapy post-placement which is a contradiction to the warnings section of the ifu.The ¿extravasation of contrast through the endoprosthesis¿ reported as ae#1 in the patient casebook was deemed unrelated to both the stent and stent placement procedure.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 1 used device.Summary of investigation: according to the initial reporter, the patient did experience an adverse effect due to this occurrence.The patient presented with extravasation of contrast through the endoprosthesis 10 days post-placement.No treatment was performed.The author of the casebook noted that the study procedure and patients pre-existing conditions were related to this adverse event with the following being noted in the casebook; ¿correctly placed esophageal prosthesis in the distal third that does not cover the entire upper cup of the esophageal circumference¿.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 16-apr-2024.

• 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: 16859387
• MDR Text Key: 314445908
• Report Number: 3001845648-2023-00316
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)220707(10)C1742025
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2024

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: 07/07/2022
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1742025
• 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: 05/03/2023
• Supplement Dates Manufacturer Received: 04/11/2023; 04/11/2023; 04/11/2023
• Supplement Dates FDA Received: 06/01/2023; 02/16/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG