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

Catalog Number EVO-FC-10-11-6-B

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  malfunction  

Event Description

When stent was ready to be fully deployed, the nurse wanted to take out the safety wire; but it wasn¿t possible to remove the red safety guard; tried it several times and finally the safety wire broke off directly at the red pin at handle end.Then partially opened stent was then recaptured and full system was taken out; procedure was finished with a new device "as per cc form": when stent was ready to be fully deployed, the nurse wanted to take out the safety wire; but it wasn¿t possible to remove the red safety guard; tried it several times and finally the safety wire broke off directly at the red pin at handle end.Then partially opened stent was then recaptured and full system was taken out; procedure was finished with a new device 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 1.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 stent placement 2.What endoscope type and channel size was used? olympus duodenoscope 4,2mm working channel 3.What was the position of the elevator? n/a 4.Details of the wire guide used (diameter, type, make)? olympus visiglide 0.035 5.Was the zip port facing upwards and slightly curved when back loading 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.Choledochus 8.How long was the stent in the patient by the time this complaint occurred? 1-2 minutes 9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a 10.If yes, how often was this completed? 11.Did the patient require any additional procedures as a result of this event? no 12.What intervention (if any) was required? procedure was finished with new device 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 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? 3-4 cm 2.Where was the stricture located in the body? choledochus 3.Was there resistance felt passing wire guide through stricture? no 4.Was there resistance felt passing the evolution through stricture? no 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? no 3.If yes, at what point? 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? yes, button was pressed to recapture stent after issue occured 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? yes 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? n/a 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? no ¿ it was not possible to remove safety wire 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? forceps, snare, other 2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? n/a, yes, no 4.If yes, please when this was felt? advancement or deployment 5.How did the physician deal with this resistance? 6.Was the lasso (suture) loop used during repositioning.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the evo-fc-10-11-6-b device of lot number c2054704 involved in this complaint was returned for evaluation, without its original opened packaging.With the information provided, a physical examination and document-based investigation was conducted.On evaluation of the devices the following was observed: visual inspection: red safety tab still in place.Directional button in deploy position.Red shuttle on 4th dimple.Safety wire still in place.Red luer returned separate to device.Functional inspection: handle actuating fine for deployment and recapture.Stent deployed with no issue.Safety wire removed with not issue.Stent released with no issue.Manufacturing records: prior to distribution, all evo-fc-10-11-6-b devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-fc-10-11-6-b of lot number c2054704 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records 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 c2054704.Instructions for use and/label: it should be noted that the instructions for use (ifu0062) which accompanies this device instructs the user to; "when stent point-of-no return has been passed, disconnect luer lock fitting to remove safety wire completely from delivery handle" 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 the torturous path causing a build-up of pressure and likely resulting in the safety wire to break and subsequently causing issues encountered with safety wire removal during the procedure.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 potential emerging trends.Summary of investigation: according to the customer, the nurse wanted to take out the safety wire; but it wasn¿t possible to remove the red safety guard during the procedure.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.From additional information provided 'procedure was finished with new device'.Investigation findings conclude that a possible root cause could be attributed to the torturous path causing a build-up of pressure and resulting in the resistance reported thus causing the safety wire to break and subsequently causing issues encountered with safety wire removal during the procedure.Complaint is confirmed based on visual and/or functional inspection.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 15-apr-2024.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: 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: 17564424
• MDR Text Key: 321971983
• Report Number: 3001845648-2023-00632
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)250519(10)C2054704
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K121430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-10-11-6-B
• Device Lot Number: C2054704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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