MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number	EVO-10-11-6-B
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The stent began to release correctly and when it had only deployed about 10 mm it could not be opened further.They removed the entire system, along with the stent, and they implanted another stent.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.At what stage of the procedure did the complaint occur? during stent placement.What endoscope type and channel size was used? duodenoscope 4.2.What was the position of the elevator? open.Details of the wire guide used (diameter, type, make)? jagwire 0.035.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.Please advise the anatomical location of the intended target site.Bile duct.How long was the stent in the patient by the time this complaint occurred? 5 minutes, when it can no longer be released, it retreats entirely.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a.If yes, how often was this completed? did the patient require any additional procedures as a result of this event? no.What intervention (if any) was required? n/a.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.If yes, please specify what was observed and where on the device it was observed.Stricture information: what was the length and diameter of the stricture? 2cm.Where was the stricture located in the body? distal bili duct.Was there resistance felt passing 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? no.If yes, at what point? questions related to during stent placement: did the product fail during stent deployment or recapture? deployment.If other, please specify.Was the directional button pressed during use? no.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? yes.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 as a cancellation report following the completion of the investigation on 23-jan-2025 as the complaint no longer meets the description of a reportable incident."no adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ no reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.".
Additional Manufacturer Narrative
Device evaluation the evo-10-11-6-b device of lot number: c2146318 involved in this complaint was returned for evaluation, with its opened original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 23 october 2024.On evaluation of the device, the following was observed: visual inspection: red safety tab not returned directional button is in recapture position safety wire returned in place red shuttle is on 9th dimple (before the point of no return) stent returned partially deployed kinks observed on the outer catheter at 80.3cm, and 121.7cm from the white tip.(ruler ipe0938-2).Functional inspection: handle is actuating with resistance, unable to deploy stent unable to remove safety wire handle opened and all clogs intact.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 (ifu0056) states the following: ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Please notify cook for return authorization.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to difficult patient anatomy.It is possible that during deployment, a tortuous path caused the delivery system to kink during advancement.The stent could not be fully deployed due to the catheter kink.It is also possible that the kink may have formed if the endoscope was in a flexed or twisted position at any stage during the procedure.During the lab evaluation it was noted that the safety wire could not be removed, this may have occurred due to the catheter being kinked which would make it difficult to remove the safety wire.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Confirmed quantity of 01 x used device.Summary of investigation according to the initial reporter, another device was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for similar events.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• 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: 19997801
• Report Number: 3001845648-2024-00483
• Device Sequence Number: 12570303
• Product Code: FGE
• UDI-Device Identifier: 10827002231280
• UDI-Public: (01)10827002231280(17)260223(10)C2146318
• Combination Product (Y/N): N
• PMA/510(K) Number: K121430
• 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): 01/23/2025

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: 02/23/2026
• Device Catalogue Number: EVO-10-11-6-B
• Device Lot Number: C2146318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown