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

Model Number G48038

Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

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

The excrement keep coming out while placing stent.The yellow mark cannot recognize at the moment which caused the procedure failure.Leave the metal stent at a wrong position in patient body.

Event Description

This follow up report is being submitted for the image review dated (b)(6)2022.Additionally, information was provided on (b)(6)2022 indicating the stent placement was monitored fluoroscopically during the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the device evaluation of evo-25-30-10-c of lot c1798731 could not be completed as the device or photographic evidence of the device was not returned for evaluation.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 number c1798731 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: there is evidence to suggest that the customer did not follow the instructions for use.The instructions for use, ifu0052 which accompanies this device, states ¿¿ an endoscopically and fluoroscopically visible yellow marker defines the proximal end of the stent when constrained in the catheter.There is no evidence to suggest the user did not follow.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: the complaint of procedure failure is not confirmed.Yellow marker obscuration was possible given the fecal material covering the distal stent.Considering the stent was placed to relieve colonic obstruction from colon cancer, the copious release of fecal material indicated procedural success despite alleged suboptimal stent location.The ifu states in the precautions section that the stent should be placed endoscopically with fluoroscopic monitoring.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As per clinical input it is possible the excrement had an impact on visualising the yellow marker.Confirmation of complaint: the complaint is confirmed based on customer/ and or rep testimony the stent was placed to relieve colonic obstruction from colon cancer, the release of faecal material indicated procedure success despite alleged suboptimal stent location.Procedure failure was not defined although it likely meant that stent was not deployed where exactly intended.Summary of investigation: according to the customer the stent was placed in the incorrect position due to not being able to visualize the yellow marker.Confirmed quantity of 1 device, confirmed used.According to the initial report, the stent did not result in any risk to patient.The stent was scheduled to be removed by elective operation two months after its initial placement.Investigation findings conclude a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As per clinical input it is possible the excrement had an impact on visualising the yellow marker.Complaint is confirmed based on customer and/or rep testimony.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.

• 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: 14043149
• MDR Text Key: 288794123
• Report Number: 3001845648-2022-00207
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)230204(10)C1798731
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1798731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2022
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 56 KG