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

Model Number	G48038
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k163468.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Event or Problem 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.
Additional 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.
Event or Problem 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.
Additional 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 could be attributed to tortuous anatomy/ a 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.It is possible that a tight stricture caused compression of the introducer which may have resulted in a build-up of pressure and as a result the stent could not be deployed.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 could be attributed to tortuous anatomy/tight stricture.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.
Event or Problem Description
Supplemental correction report is being submitted to include update to imdrf codes and investigation evaluation notes on 29-nov-2024.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: 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: 16782761
• Report Number: 3001845648-2023-00258
• Device Sequence Number: 17562604
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)240826(10)C1973003
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 02/17/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/27/2023; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male