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

Model Number G23129

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per email: red safety wire leur lock fitting separated from wire when pulled, leaving wire within device and attached to stent.Introducer was then pulled attempting to remove but not realizing still connected to safety wire ¿ this deformed the stent and caused a loop of wire to exit the papilla once the safety wire was removed.A plastic stent was then deployed below, but in doing so that introducer pushed the metal stent up into the hepatics.Patient outcome: the following information has been requested via email on (b)(6) 2023.Sg (b)(6)2023 did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? did the patient require any additional procedures due to this occurrence? did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Patient/event info - notes: the following information has been requested via email on (b)(6) 2023.Sg (b)(6) 2023 general questions: 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) what endoscope type and channel size was used? what was the position of the elevator? n/a, open, closed.Details of the wire guide used (diameter, type, make)? was the zip port facing upwards and slightly curved when backloading the wire guide? did any part of the stent contact the patient¿s anatomy when the complaint occurred? please advise the anatomical location of the intended target site.How long was the stent in the patient by the time this complaint occurred? for devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? if yes, how often was this completed? did the patient require any additional procedures as a result of this event? what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? if yes, please specify what was observed and where on the device it was observed.Should the difficulty involve a stricture, request the following: what was the length and diameter of the stricture? where was the stricture located in the body? was there resistance felt passing wire guide through stricture? was there resistance felt passing the evolution through stricture? was the stricture dilated before stent placement? should the difficulty occured during insertion into the patient, request the following: was the product inspected for kinks or damage before use? was resistance felt during insertion into patient? if yes, at what point? should the difficulty occur during stent placement, request the following: did the product fail during stent deployment or recapture if other, please specify.Was the directional button pressed during use? was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? was the yellow marker kept in view during deployment? are images of the device or procedure available? should the difficulty occur during introducer withdrawal, request the following: are images of the device or procedure available? was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? did the stent open sufficiently to allow withdrawal of introducer safely? was the safety wire fully removed before removing the delivery system? did any part of the product snag/get caught with the stent when removing the delivery system? the following information has been requested via email by pmqe on (b)(6) 2023.Sg (b)(6) 2023 was the distal end of the catheter formed manually? how was the device deployed?.

Manufacturer Narrative

Cancellation report is being submitted due to additional information received on 19-feb-2024.Fda mdr reporting not required.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Device evaluation: the 01x evo-10-11-8-b device of lot number c1895564 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Multiple attempts at obtaining additional information from the rep/customer were made and the following answer was received: ¿the lead rn called on (b)(6) 2023 to let me know that she does not have the information being requested and she is not going to pull the records from march to look up the additional information when the rep was in the procedure, and he should have provided that information to us when it was reported.¿.The complaint will be investigated with the initial information provided, should any additional information become available, the complaint will be updated accordingly.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 relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: as per the instructions for use's (ifu0056) warnings section: "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.According to product manager input, as the used only attempted to remove the stent due to the red leur separation happening when removing the safety wire, this is not deemed use error.Furthermore, there is nothing within the ifu that disallows the user to place a plastic stent within an evo-b device.Also, the plastic stent was placed as a result of the deformation to the evo-b which has been deemed a cascading effect of the red-leur separation when removing the safety wire.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to excessive force being applied to the red leur when attempting to remove the safety wire after passing the point of no return.This in turn caused the stent to deform when the user attempted to remove the introducer with the stent partially deployed.Another possible root cause could be attributed to a kink in the delivery system of the device that subsequently could have caused the safety wire to kink and become difficult to remove however, as the device was not returned for evaluation and the user did not report any kinks, this possible root cause is not confirmed.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01x used device.Summary of investigation: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.According to the customer/rep testimony, once the stent was deformed, a plastic stent was placed within the lumen of the metal stent.The introducer of the plastic stent pushed the evo-b into the hepatics.There was no patient outcome reported by the customer and/or rep.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Cancellation report is being submitted due to additional information received on 19-feb-2024.Fda mdr reporting not required.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• 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: 16643152
• MDR Text Key: 312614952
• Report Number: 3001845648-2023-00199
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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 Expiration Date: 12/09/2023
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C1895564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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
• Patient Age: 83 YR
• Patient Sex: Female