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 Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/14/2023

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

Dr (b)(6) introduced system over wire guide and when position was correct, with the help of a nurse, started deploying the stent *(removing ref safety guard first), they heard a crushing noise at the beginning of the deployment, continued squeezing triger but none of the stent came out.Looking at the stent, it also appears to be kinked at the end of the flexor.They used another cook colonic stent without any issue.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 21-nov-2023.

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the evo-25-30-8-c device of lot number c1891741 involved in this complaint was returned for evaluation, without the original 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 10th oct 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.Safety wire not returned.Directional button in recapture position.Red shuttle pass point of no return.Flexor break observed at the end of handle.Stent is present within the delivery system.Functional inspection: handle actuating fine for deployment and recapture.Unable to deploy stent.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 notes section of the ifu (ifu0052), the following is listed ¿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 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 the tortuous anatomy/tight stricture, which subsequently may have caused a build-up of pressure causing deployment difficulties and led to outer sheath break (flexor break) like the one noted in the lab evaluation carried out.This excessive strain placed on the device possible generate the ¿crushing noise¿ that was heard by the user and mentioned in the testimony, likely while the outer sheath broke (flexor break).From additional information provided ¿looking at the stent, it also appears to be kinked at the end of the flexor.¿, it may be noted that there was no kinks observed during the lab evaluation, flexor break observed on returned device.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device was placed without a health consequence within the same procedure as per the additional information received back from the area rep.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 17905288
• MDR Text Key: 325293980
• Report Number: 3001845648-2023-00774
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)231130(10)C1891741
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1891741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2023
• Event Location: Hospital
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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