MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number EVO-25-30-8-C

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/24/2023

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

The prosthesis made a strange noise and it didn't release."as per cc form": when they started to release the stent, it made a strong noise and it didn't release this complaint will capture 01x case of use error for not inspecting the device prior to use.A section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.Another stent 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? during stent placement 2.What endoscope type and channel size was used? olympus 3,7 channel 3.What was the position of the elevator?.Open 4.Details of the wire guide used (diameter, type, make)? visiglide guidewire 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, yes, 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.Colon 8.How long was the stent in the patient by the time this complaint occurred? i don't know 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? another stent 12.What intervention (if any) was required? another stent 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)? 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? 2.Where was the stricture located in the body? 3.Was there resistance felt passing wire guide through stricture? n/a, yes, no 4.Was there resistance felt passing the evolution through stricture? n/a, yes, no 5.Was the stricture dilated before stent placement? n/a yes, no questions related to during insertion into patient 1.Was the product inspected for kinks or damage before use? no 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? n/a, yes, no.Yes, it was checked 4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a, yes, no.5.Was the yellow marker kept in view during deployment? yes 6.Are images of the device or procedure available? not 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 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

Pma/510(k) # k163468.Device evaluation: the evo-25-30-8-c device of lot number c1968827 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 following were also raised in response to this complaint occurrence: ¿ (b)(4) - the prosthesis made a strange noise and it didn't release the device related to this occurrence underwent a laboratory evaluation on the 08th mar 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 in place, ¿ directional button in deploy position, ¿ red marker at 5th dimple, ¿ safety wire still in place, ¿ significant kink on flexor just beside handle.* functional inspection: ¿ handle actuating fine for deployment and recapture, ¿ stent deployed with no issue and intact, ¿ safety wire removed and stent released with no issues.Note 1: as per the additional questions asked, the customer confirmed that there were no other defects other than the complaint issue of deployment difficulty.¿14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? not¿.Therefore, the product likely sustained the kink noted in the lab evaluation during transport and/or storage back 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 evidence to suggest that the customer did not follow the instructions for use.As per the instructions for use (ifu0052) notes section "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." as per customer/rep testimony from the additional information answers, the user did not inspect the device for kinks or damage before use and therefore, this complaint will capture this occurrence of use-error.User/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of use-error was identified from the available information.As per the customer and/or rep testimony the answer to the question ¿1.) was the product inspected for kinks or damage before use?¿ with the answer being ¿no¿.This is a contradiction to the ifu¿s notes section quoted above.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.The user stated that once the device was removed, another stent was placed as a result.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 22-mar-2024.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• 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: 18333987
• MDR Text Key: 330551514
• Report Number: 3001845648-2023-00909
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)240812(10)C1968827
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/22/2024

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-25-30-8-C
• Device Lot Number: C1968827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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