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

Catalog Number	EVO-FC-18-23-12-E
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As initially reported to customer relations: a patient of undisclosed gender and age underwent an esophageal stent placement procedure to treat an esophageal mass in which the evolution esophageal controlled-release stent- fully covered, g51183, was used.The stent became displaced.The stent had to be retrieved from the patient's mouth using forceps.Patient/event info - notes: general questions: at what stage of the procedure did the complaint occur? while removing the introducer when unpacking or preparing the evolution while inserting the evolution in the patient during stent placement while removing the introducer **** this one**** during stent repositioning/removal what endoscope type and channel size was used? n/a what was the position of the elevator? n/a was it opened or closed? details of the wire guide used (diameter, type, make)? savary.035 guidewire, 250cm did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes how long was the stent in the patient by the time this complaint occurred? 30 seconds for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? stricture information: what was the length of the diameter of the stricture? 9cm where was the stricture located in the body? esophagus was there resistance felt passing the wire guide through stricture? no was there resistance felt passing the evolution through stricture? no was the stricture dilated before stent placement? no questions related to during insertion into patient was the product inspected for kinks or damage before use? yes was resistance felt during insertion into patient? if yes, at what point? no questions related to during stent placement did the product fail during stent deployment or recapture? no was the directional button pressed during use? yes was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes was the yellow marker kept in view during deployment? n/a are images of the device or procedure available? no.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 05-nov-2024.
Additional Manufacturer Narrative
Device evaluation: the evo-fc-18-23-12-e device of lot number c2135070 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.It was confirmed with the customer that the stent was not connected to the delivery system through the safety wire when the event occurred.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.Historical data review: the review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: it should be noted that the instructions for use (ifu0061) lists ¿stent misplacement and/or migration¿ as a potential adverse event.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 analysis: a definitive root cause could not be determined.A possible root cause can be attributed to difficult patient anatomy / a tight stricture.It is possible that a tight stricture compressed the deployed stent against the white tip of the introducer, thus causing the stent to move during withdrawal of the introducer.However, as the device was not returned for evaluation, the cause of this complaint could not be conclusively determined.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01 x used device.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the initial reporter, the stent became displaced 30 seconds after initial placement.The stent was retrieved using forceps.There was no adverse effect to the patient as a result of this occurrence.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 19331429
• Report Number: 3001845648-2024-00222
• Device Sequence Number: 14222160
• Product Code: ESW
• UDI-Device Identifier: 10827002511832
• UDI-Public: (01)10827002511832(17)260123(10)C2135070
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K093619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2026
• Device Catalogue Number: EVO-FC-18-23-12-E
• Device Lot Number: C2135070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown