MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User opened the package, and felt obvious resistance while deploy stent.User retracted the device from patient and found out the conjunction between sheath and handle bent.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) stent placement.2.What endoscope type and channel size was used? olympus duodenoscope.3.What was the position of the elevator? was it opened or closed? open.4.Details of the wire guide used (diameter, type, make)? 0.035'' wire guide(microport).5.Was the zip port facing upwards and slightly curved when backloading the wire guide? no.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.Duodenal papilla.8.How long was the stent in the patient by the time this complaint occurred? none.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? 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? n/a.13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.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? 2cm.2.Where was the stricture located in the body? duodenal papilla.3.Was there resistance felt passing wire guide through stricture? no.4.Was there resistance felt passing the evolution through stricture? yes.5.Was the stricture dilated before stent placement? yes.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? if yes, at what point? no.Questions related to during stent placement.1.Did the product fail during stent deployment or recapture? no.2.Was the directional button pressed during use? no.3.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? none.4.Was the yellow marker kept in view during deployment? yes.5.Are images of the device or procedure available? no.Questions related to during introducer withdrawal.1.Was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? x-ray.2.Did the stent open sufficiently to allow withdrawal of introducer safely? yes.3.Was the safety wire fully removed before removing the delivery system? there issue during stent deployment.4.Did any part of the product snag/get caught with the stent when removing the delivery system? no.5.Are images of the device or procedure available? no.Questions related to during stent repositioning/removal.1.What instrument was used for stent repositioning removal? forceps, snare n/a.2.Was the lasso (suture) loop used during repositioning removal? no.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 07-jul-23.

Manufacturer Narrative

Pma/510(k) #k163468 device evaluation: the 1x evo-22-27-12-d device of lot number c1917446 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 11 may 2023.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device, the following was observed: visual inspection: ¿ red safety tab not returned.¿ directional button in neutral position.¿ red shuttle at last dimple.¿ safety wire not returned.¿ flexor kink below handle.¿ stent not returned.¿ kink observed on inner catheter approx.24.4cm from white tip.Functional inspection: ¿ actuating fine for deployment and recapture.Note 1: images were received from the customer.Image 1 shows the flexor kink below the handle.This aligns with cirl¿s findings during the lab evaluation.Image 2 shows the product box label which aligns with the rpn and lot# that was returned to cirl for evaluation.Note 2: the customer/rep was contacted to determine if the stent was placed in the patient or if it was discarded prior to shipment.The rep responded confirming that the stent had been discarded prior to shipment to cirl for evaluation.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: there is no evidence to suggest that the customer did not follow the instructions for use or product label.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.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor kinking.The pressure build-up of attempting to deploy with a kinked flexor would have been felt through trigger resistance described by the customer.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Summary of investigation: according to the customer/rep testimony; while deploying the stent, obvious resistance was felt.When the user removed the system from the patient it was found that the conjunction between the handle and sheath was bent.Confirmed quantity of 01 used device.The investigation findings concluded a possible root cause could be attributed to torturous patient anatomy.It was deemed possible that during deployment, a torturous path may have caused a build-up of pressure resulting in the kinked flexor.Complaint is confirmed based on visual and/or functional inspection.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.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: 16032877
• MDR Text Key: 308363322
• Report Number: 3001845648-2022-00922
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)240225(10)C1917446
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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 Expiration Date: 02/25/2024
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1917446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male