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 Fistula (1862); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stent #1: evo-fc-r-20-25-10-e (c1472259) (b)(4).Procedure: was the stent placed at the intended location at completion of the procedure? yes.Were any additional procedure (s) performed during the study procedure? yes-peg (percutaneous endoscopic gastrostomy).Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.Adverse event: migration of the prosthesis (b)(4).Event treatment: new stent placed (non-study stent) cook evolution.Was the event considered to be related to the study device? not related.Was the event considered to be related to the study procedure? not related.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? yes-boerhaave syndrome.Did the event occur due to a device deficiency no.Patient outcome: at the conclusion of follow-up what was the status of the study stent: stent removed endoscopically.Days post stent placement: 20.Reason for removal: adverse event.Event status at time of study exit: resolved (patient recovered/stabilized).

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation: 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.The device evaluation for the evo-fc-r-20-25-8-e device of lot c1472259 could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file is related to (b)(4) (emdr ref.- 3001845648-2022-00841).Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c1472259 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label the instructions for use which accompanies this device, states ¿¿ this device is used to maintain luminal patency of the esophagus in cases of; obstruction cause by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.Root cause analysis: definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.The instruction for use advises that the intended use ¿¿ this device is used to maintain luminal patency of the esophagus in cases of; obstruction cause by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas.¿¿ it is known from the available information that the stent was used to treat a esophago-gastric fistula.It is likely the off-label use of the stent would have contributed to the migration of the stent.Summary of investigation: according to the pmcf study stent migration occurred.Confirmed quantity of 1 device, confirmed used.According to the initial report the stent was removed endoscopically 20 days post placement and at the time of the study exit the patient had recovered/stabilized.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.The instruction for use advises that the intended use ¿¿ this device is used to maintain luminal patency of the esophagus in cases of; obstruction cause by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas.¿¿ it is known from the available information that the stent was used to treat a esophago-gastric fistula.The off-label use of the stent would have contributed to the migration of the stent.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• 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: 15914556
• MDR Text Key: 304791636
• Report Number: 3001845648-2022-00829
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551715
• UDI-Public: (01)10827002551715(17)200409(10)C1472259
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: 04/09/2020
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1472259
• 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: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG