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 Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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
In doing count and told that lot c1958996 (that was billed yesterday ) had a problem.Pc = they went down the scope with the stent.When they started to deploy it wouldn't deploy.Stent appears jammed.Product returning for analysis.As per cc form: "the stent was deployed over the wire down the scope but when the nurse started to deploy it it would not go past a certain point regardless if it was retracted or not." a section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.They had to use an additional stent to complete the case 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? when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal during placement.What endoscope type and channel size was used? aquilant duodenal scope serial number (b)(4).What was the position of the elevator? n/a, open, closed n/a.Details of the wire guide used (diameter, type, make)? awg2 0.35.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, yes, no.N/a.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? n/a, yes, no.Yes.Please advise the anatomical location of the intended target site.Cbd.How long was the stent in the patient by the time this complaint occurred? a few minutes.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, yes, no n/a.If yes, how often was this completed? did the patient require any additional procedures as a result of this event? n/a, yes, no, yes.What intervention (if any) was required? a further stent was required was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day / same day.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.No 15.If yes, please specify what was observed and where on the device it was observed.Stricture information: 1.What was the length and diameter of the stricture? not known where was the stricture located in the body? cbd.Was there resistance felt passing wire guide through stricture? n/a, yes, no no.Was there resistance felt passing the evolution through stricture? n/a, yes, no no.Was the stricture dilated before stent placement? n/a yes, no.No.Questions related to during insertion into patient was the product inspected for kinks or damage before use? n/a, yes, no yes.Was resistance felt during insertion into patient? n/a, yes, no no.If yes, at what point? questions related to during stent placement did the product fail during stent deployment or recapture? n/a, deployment, recapture, other no.If other, please specify was the directional button pressed during use? n/a, yes, no yes.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a, yes, no/ yes.Was the yellow marker kept in view during deployment? n/a, yes, no yes.6.Are images of the device or procedure available? n/a, yes, no] device will be returned questions related to during introducer withdrawal are images of the device or procedure available? n/a, yes, no device will be returned.Was final stent placement confirmed using endoscopy / fluoroscopy? n/a, yes, no.No.If yes, what was used? did the stent open sufficiently to allow withdrawal of introducer safely? n/a, yes, no no.Was the safety wire fully removed before removing the delivery system? n/a, yes, no no.6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a, yes, no yes all of it as they could not deploy it.Questions related to during stent repositioning/removal (for evo-fc & evo-pc devices) what instrument was used for stent repositioning / removal? forceps, snare, other n/a.If other, please specify.Was resistance encountered during advancement and/or deployment? n/a, yes, no.Yes.If yes, please when this was felt? advancement or deployment.Deployment how did the physician deal with this resistance? removed stent and started procedure with a new one was the lasso (suture) loop used during repositioning no.
Additional Manufacturer Narrative
Device evaluation: the evo-10-11-8-b device of lot number c1958996 involved in this complaint device was not returned for evaluation.With the information provided a document-based investigation was conducted.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 c1958996 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 c1958996 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0056 that accompanies this device states ¿¿ visually insect 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 as the device was not returned for evaluation.A possible root cause could be attributed to difficult patient anatomy.From available information it is known that there was resistance encountered during advancement , it is possible that this resulted in an excessive force being placed on the delivery system during advancement and subsequent attempted deployment which may have resulted in the stent appearing to jam and being unable to be deployed.Please note multiple requests were made to get this device returned and evaluated in the laboratory but these were unsuccessful, if this should become available at a later date the investigation will be re-opened and updated to match the findings.Confirmation of complaint complaint is confirmed based on the customers and/or rep testimony summary of investigation according to the customer the stent failed to deploy.Confirmed quantity of 1 device, confirmed used.Investigation findings conclude a possible root cause of difficult patient anatomy causing stent deployment issues.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on the customers and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This supplemental report is being submitted due to completion of the investigation on the 18-may-2023.

• 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: 15940355
• Report Number: 3001845648-2022-00852
• Device Sequence Number: 6219718
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)240707(10)C1958996
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 07/07/2024
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C1958996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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