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 Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Dysphasia (2195)

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

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? no.Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.Adverse event: stent migration + dysphagia.Placement of a fully covered esophageal prosthesis on 02/23/17, migration of the same so that on 07/14/2017 the stenosis was dilated to 12 mm.Adverse event onset (days post stent placement): 141.Event treatment: endoscopic dilatation with pneumatic balloon progressively up to 13 mm.Was the event considered to be related to the study device? related.If related, please provide a detail description of how study device caused or contributed to this event: a migrated prosthesis is observed.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? no.Did the event occur due to a device deficiency? migrated prothesis event status at time of study exit: resolved (patient recovered/stabilized).

Manufacturer Narrative

Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required the device evaluation for evo-fc-r-20-25-8-e of lot c1396854 could not be completed as the device or photographic evidence of the device was not returned for evaluation.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 c1396854 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1396854 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0067 which accompanies this device, instructs the user that: ¿the safety and effectiveness of leaving this stent in place, or removing the evolution esophageal stent ¿ fully covered from a benign lesion beyond 8 weeks has not been established.¿ there is evidence to suggest that the customer did not follow the instructions for use.Root cause analysis: a definitive root cause was established.The stent has been left in place for 141 days which is beyond the recommended 56 days (8 weeks) the instructions for use, ifu0067 which accompanies this device, instructs the user that: ¿the safety and effectiveness of leaving this stent in place, or removing the evolution esophageal stent ¿ fully covered from a benign lesion beyond 8 weeks has not been established.It is possible that the user error of the stent being left in place beyond the recommended weeks contributed to the stent migration and dysphagia.Confirmation of complaint: complaint is confirmed based on customer testimony.Summary of investigation: according to the pmcf study a migrated stent and dysphagia was documented 141 days post stent placement.Confirmed quantity of 1 device, confirmed used.According to the initial report at the time of the study exit the patient had recovered/stabilized.Investigation findings conclude a definitive root cause was established.The stent has been left in place for 141 days which is beyond the recommended 56 days (8 weeks).The instructions for use, ifu0067 which accompanies this device, instructs the user that: ¿the safety and effectiveness of leaving this stent in place, or removing the evolution esophageal stent ¿ fully covered from a benign lesion beyond 8 weeks has not been established.It is possible that the user error of the stent being left in place beyond the recommended weeks contributed to the stent migration and dysphagia.Complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final report due to completion of final investigation on 08-may-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: 15914868
• MDR Text Key: 304816009
• Report Number: 3001845648-2022-00831
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)190907(10)C1396854
• 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: 05/08/2023

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: 09/07/2019
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1396854
• 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: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG