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); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
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
When the doctor tried recaptured the stent was not possible to do it correctly and they need implant another one "as per cc form": they introduced the wire, after the stent but was a big stenosis, they started to open, after they tried to recover the stent to replace in a higher position but it was not possible to close the stent totally and continue using the system lab evaluation complete on 25-apr-2022: visual inspection: stent partially deployed on return.Marker between 3rd and 4th dimpling.Lock wire in place on return.Flexor (clear section) kinked approximately 12cm from the tip.Functional inspection: advancement and recapture was possible.Lock wire removed and stent deployed with some resistance 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 = repositioning the stent 2.What endoscope type and channel size was used? olympus 180 3.What was the position of the elevator? n/a, open, closed 4.Details of the wire guide used (diameter, type, make)? jagwire 35-260 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? yes 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.Bile duct.8.How long was the stent in the patient by the time this complaint occurred? seconds but partially.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, yes, no.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? 13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? in the same time using another stent.14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? not.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 specific.2.Where was the stricture located in the body? bile 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? n/a yes, no.Not 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? crossin the duct.Questions related to during stent placement 1.Did the product fail during stent deployment or recapture? n/a, recapturing.2.If other, please specify.3.Was the directional button pressed during use? not.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? ] yes.Questions related to during introducer withdrawal 1.Are images of the device or procedure available? n/a, yes, no.2.Was final stent placement confirmed using endoscopy / fluoroscopy? n/a, yes, no.3.If yes, what was used? 4.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a, yes, no.5.Was the safety wire fully removed before removing the delivery system? n/a, yes, no.6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a, yes, no.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 repositon recapturing the stent.2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? yes.4.If yes, please when this was felt? advancement or deployment recapturing.5.How did the physician deal with this resistance? retairing all th evolution sistem.6.Was the lasso (suture) loop used during repositioning not.
Additional Manufacturer Narrative
Device evaluation: 1 unit of evo-10-11-8-b lot# c1844232 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 25 apr 2022.On evaluation of the device the following was observed: visual inspection: stent partially deployed on return.Marker between 3rd and 4th dimpling.Lock wire in place on return.Flexor (clear section) kinked approximately 12cm from the tip.Functional inspection: advancement and recapture was possible.Lock wire removed and stent deployed with some resistance.Documents review including ifu review: prior to distribution evo-10-11-8-b devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-10-11-8-b of lot number c1844232 did not reveal any discrepancies that could have contributed to this complaint issue.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 c1844232.It should be noted that the instructions for use (ifu0056) states the following: "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is not sufficient evidence to suggest the user did not follow the ifu.Image review: n/a.Root cause review: 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 patient anatomy.It is known from information received that resistance was felt passing the evolution system through the stricture which could have caused the introducer to kink and cause the deployment/recapture issue reported.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 30-jan-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: 14235970
• Report Number: 3001845648-2022-00257
• Device Sequence Number: 14527485
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)230625(10)C1844232
• 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): 01/30/2023

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: 06/25/2023
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C1844232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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: Male