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

Model Number G48038

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There is obstruction at patient's connecting portion between the descending colon and sigmoid colon which need to implant a stent.User advanced the endoscopy to obstruction area and placed a wire guide through a catheter, and observed the wire guide passed the obstruction area under x-ray image, then user advanced the stent delivery system through the wire guide and passed the obstruction area with great effort.Afterward user detected the stent cannot be self expanded after partial deployment as expected.But the red mark almost reached no retraction mark, user worried of continue releasing the stent and retracted the stent back into delivery system instead.User checked the stent is intact and can be released as expected after retracting from patient, and decided put the delivery system back into patient to deploy the stent again, but the stent still cannot be expanded as expected.User then changed to boston scientific similar device to complete the procedure.Patient outcome: "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." lab evaluation completed on 23 march 2023.

Event Description

Supplement follow-up report is being submitted due to the completion of the investigation on 29-may-2023 and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k163468 device evaluation: the device evaluation of the evo-25-30-10-c of lot c1973003 was completed on 23rd mar 2023.On evaluation of the device: red safety tab not returned.Directional button in recapture position.Red marker at 3rd dimple.Safety wire still in place.Kink observed on outer flexor below the handle.Handle actuating fine for deployment and recapture of stent.Stent deployed fully with no issues and is intact.Safety wire released with no issue.As per image provided by customer device appears to be intact.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1973003 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1973003 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0053 that accompanies this device states ¿¿ visually insect 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.Image review: an image was not returned for evaluation.Root cause analysis a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause of the kinked flexor observed in the lab is most likely due tortuous anatomy/tight stricture.It is known from customer feedback that the user advanced the stent delivery system through the wire guide and passed the obstruction area with great effort.This could have led to the flexor becoming kinked and subsequent issue deploying the stent.It should be noted that the stent deployed with no issues and was intact when evaluated.Confirmation of complaint complaint is confirmed based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.Summary of investigation according to the customer the user experienced stent deployment issues.Confirmed quantity of 1 device, confirmed used.Investigation findings conclude a possible root cause of the kinked flexor is most likely due tortuous anatomy/tight stricture.In the efforts to pass the obstruction i believe the flexor was kinked which led to stent deployment issue.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 16782761
• MDR Text Key: 314166207
• Report Number: 3001845648-2023-00258
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)240826(10)C1973003
• 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: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1973003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2023
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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: 70 YR
• Patient Sex: Male