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 Problem Break (1069)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When the nurse activated the trigger of the prosthesis, a click was heard and it was impossible to release the prosthesis.The device was retained."as per cc form": prosthesis kept sound of "clicking" when activating the handle to release the prosthesis.The prosthesis did not release.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 doctor wanted to deployed stent.2.What endoscope type and channel size was used? fuji ed-580xt / 4.2mm.3.What was the position of the elevator? open, 4.Details of the wire guide used (diameter, type, make)? jagwire 035 - 260.5.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? n/a.7.Please advise the anatomical location of the intended target site.Biliary tract 8.How long was the stent in the patient by the time this complaint occurred? na.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? 13.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 14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? nc.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? nc.2.Where was the stricture located in the body? biliary tract.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? n/a, 2.If other, please specify 3.Was the directional button pressed during use? n/a, 4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a, 5.Was the yellow marker kept in view during deployment? n/a, 6.Are images of the device or procedure available? n/a.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? 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? forceps, snare, other : na.2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? yes : impossible to deploy 4.If yes, please when this was felt? deployment.5.How did the physician deal with this resistance? no success.6.Was the lasso (suture) loop used during repositioning : na.

Manufacturer Narrative

Device evaluation: the 01x evo-fc-10-11-6-b device of lot number c1986678 involved in this complaint was returned for evaluation, with its original opened packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 18st jul 2023.On evaluation of the device, the following was observed: visual inspection: red safety tab not returned, directional button in neutral position, safety wire still in place, red shuttle on 8th dimple, flexor returned in two separate pieces.Flexor break observed approx 132cm from distal end of catheter, kinks observed 129cm and 130cm from distal end of white tip, ruler used: ipe0504-4.Functional inspection: handle actuating with slight resistance from deployment and recapture, unable to deploy stent, safety wire removed with no issue.User clarified that damage noted during the lab evaluation occurred during the procedure.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: it should be noted that the instructions for use (ifu0062) which accompanies this device, instructs the user to; "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 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 torturous patient anatomy.As noted in the lab evaluation, the flexor/outer catheter was kinked and broken upon return.It is possible that during deployment, a tortuous path may have caused a kink in the flexor and continued attempts to deploy may have led to a build-up of pressure at the kink resulting in the flexor breaking.This build-up of pressure and continued attempts to deploy could have contributed to the ¿clicking noise¿ that was reported in the customer testimony also.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Confirmed quantity of 01 used device.Summary of investigation: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplement report being submitted due to the completion of the investigation on 13-oct-23.

• 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: 17549063
• MDR Text Key: 321200350
• Report Number: 3001845648-2023-00629
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)241007(10)C1986678
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• 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: 10/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-10-11-6-B
• Device Lot Number: C1986678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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