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

Model Number	G23129
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When releasing, snapping and then impossible to release the prosthesis, broken.
Additional Manufacturer Narrative
Device evaluation: the evo-10-11-8-b device of c2197669 lot number involved in this complaint was returned opened in its original packaging.With the information provided, a physical examination and document based investigation was conducted.It may be noted that there has been several attempts made to clarify device returned process, from additional information provided "i probably wrote the wrong pcfr on the package.I picked up by my self the stent to the customer because ups refused to do it.I found an email that i sent to customer (b)(4) beginning of december." manufacturing records review: prior to distribution, all evo-10-11-8-b devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-10-11-8-b device of lot number c2197669 did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: a review of the manufacturing records for the evo-10-11-8-b device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2197669.Instructions for use and/label review: it should be noted that as per ifu0056 which accompanies this device instructs the user to inspect the device prior to 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".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.A possible root cause could be contributed to the torturous path causing a build-up of pressure and resulting in the flexor becoming severely kinked causing issues reported.Additionally a possible root cause could be attributed the device kinking on device preparation or insertion into the scope.From additional information provided there has been resistance encountered when advancing the wire guide through the obstructed area, also there was resistance encountered when advancing the introduction system in place.In addition there was resistance felt during insertion into patient.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, when releasing, snapping and then impossible to release the prosthesis.Broken.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined.A possible root cause could be contributed to the torturous path.Complaint is confirmed based on visual and/or functional inspection.
Event or Problem Description
A supplemental report is being submitted due to the completion of the investigation on 06-may-2025.Additional information received on 10-feb-2025: general questions: 1.At what stage of the procedure did the complaint occur? during stent placement 2.What endoscope type and channel size was used? 4,2.3.What was the position of the elevator? open.4.Details of the wire guide used (diameter, type, make)? jagwire.5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a.6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.7.Please advise the anatomical location of the intended target site.Biliary duct 8.How long was the stent in the patient by the time this complaint occurred? na.11.Did the patient require any additional procedures as a result of this event? yes.12.What intervention (if any) was required? boston stent.13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Stricture information: 1.What was the length and diameter of the stricture? na.2.Where was the stricture located in the body? biliary duct.3.Was there resistance felt passing wire guide through stricture? yes.4.Was there resistance felt passing the evolution through stricture? yes.5.Was the stricture dilated before stent placement? no.Questions related to during insertion into patient 1.Was the product inspected for kinks or damage before use? yes 2.Was resistance felt during insertion into patient? yes 3.If yes, at what point? na questions related to during stent placement 1.Did the product fail during stent deployment or recapture? deployment, 2.If other, please specify 3.Was the directional button pressed during use? no 4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes 5.Was the yellow marker kept in view during deployment? n/a, 6.Are images of the device or procedure available? no] questions related to during introducer withdrawal.1.Are images of the device or procedure available? no 2.Was final stent placement confirmed using endoscopy / fluoroscopy? yes 3.If yes, what was used? 4.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a, 5.Was the safety wire fully removed before removing the delivery system? n/a, 6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a, questions related to during stent repositioning/removal (for evo-fc & evo-pc devices).1.What instrument was used for stent repositioning / removal? other.2.If other, please specify.Nothing.3.Was resistance encountered during advancement and/or deployment? yes.4.If yes, please when this was felt? deployment.5.How did the physician deal with this resistance? nothing.6.Was the lasso (suture) loop used during repositioning no.

• 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 ; 061334440
• MDR Report Key: 21175710
• Report Number: 3001845648-2025-00026
• Device Sequence Number: 15610862
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)260725(10)C2197669
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/24/2024

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: 07/25/2026
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C2197669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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