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

Model Number G48038

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Date 04/26/2022

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

Complaint called in by dm on28apr2022--did 28apr2022.As reported to customer relations: "this was user error.When they went to deploy the stent, the assistant pushed the button to recapture instead of pushing it to deploy.By doing that, part of the catheter (by the handle) separated.They noticed the separation when they realized they needed to push the button in the other direction and the device wouldn't deploy.They were able to remove the cook device without issue.They ended up using a competitor device (boston duodenal stent) in the colon because they didn't have another cook device handy.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no if yes, please describe.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no if yes, please describe.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of a lab evaluation on 26-aug-2022: visual inspection - lock wire is in place on return.Red marker at 9th dimpling.Functional inspection - handle is actuating fine for deployment and recapture.Unable to deploy the stent.Lock wire removed without any issues.Complaint called in by dm on 28apr2022--did 28apr2022.As reported to customer relations: "this was user error.When they went to deploy the stent, the assistant pushed the button to recapture instead of pushing it to deploy.By doing that, part of the catheter (by the handle) separated.They noticed the separation when they realized they needed to push the button in the other direction and the device wouldn't deploy.They were able to remove the cook device without issue.They ended up using a competitor device (boston duodenal stent) in the colon because they didn't have another cook device handy.1.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.3.Did the patient require any additional procedures due to this occurrence? no.4.Did the product cause or contribute to the need for additional procedures? no.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.1.Did any unintended section of the device remain inside the patient¿s body? no.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.3.Did the patient require any additional procedures due to this occurrence? no.4.Did the product cause or contribute to the need for additional procedures? no.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to a lab re-evaluation completed on 03rd oct 2022 : visual inspection flexor separated at handle.Complaint called in by dm on 28apr2022--did 28apr2022.As reported to customer relations: "this was user error.When they went to deploy the stent, the assistant pushed the button to recapture instead of pushing it to deploy.By doing that, part of the catheter (by the handle) separated.They noticed the separation when they realized they needed to push the button in the other direction and the device wouldn't deploy.They were able to remove the cook device without issue.They ended up using a competitor device (boston duodenal stent) in the colon because they didn't have another cook device handy.Lab evaluation 26th august 2022 visual inspection lock wire is in place on return red marker at 9th dimpling catheter at handle separated functional inspection handle is actuating fine for deployment and recapture unable to deploy the stent lock wire removed without any issues.1.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no if yes, please describe.3.Did the patient require any additional procedures due to this occurrence? no if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? no please specify adverse effects and provide details.1.1 general questions: 1.1.1 at what stage of the procedure did the complaint occur? when unpacking or preparing the evolution while inserting the evolution in the patient during stent placement this one while removing the introducer during stent repositioning/removal 1.1.2 what endoscope type and channel size was used? olympus scope, model unknown (may have been adult colonoscope or double channel scope) 1.1.3 what was the position of the elevator? n/a no elevator on the scope.Was it opened or closed? 1.1.4 details of the wire guide used (diameter, type, make)? asku 1.1.5 did any part of the stent contact the patient¿s anatomy when the complaint occurred? no 1.1.6 how long was the stent in the patient by the time this complaint occurred? n/a stent wasn't in contact with patient.1.1.7 for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? n/a 1.2 stricture information: 1.2.1 what was the length of the diameter of the stricture? asku 1.2.2 where was the stricture located in the body? sigmoid 1.2.3 was there resistance felt passing the wire guide through stricture? asku 1.2.4 was there resistance felt passing the evolution through stricture? asku 1.2.5 was the stricture dilated before stent placement? asku 1.4 questions related to during stent placement 1.4.1 did the product fail during stent deployment or recapture? deployment.1.4.2 was the directional button pressed during use? yes 1.4.3 was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? no 1.4.4 was the yellow marker kept in view during deployment? asku 1.4.5 are images of the device or procedure available? asku.

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the device evaluation of the evo-25-30-10-c of lot c1850270 was completed on 26th aug 2022.On evaluation of the device the lock wire was in place on return.The red marker was at the 9th dimple.The handle actuated fine for deployment and re capture.Unable to deploy the stent.Lock wire was removed with no issue.Device re-evaluation took place on 03rd oct 2022, and the flexor was observed separated at the handle.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 c1850270 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 c1850270 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0052 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 broken flexor breaking is most likely tortuous anatomy/tight stricture.The red marker was found to be at the 9th dimpling in the lab evaluation, this means the user was attempting to deploy the stent.In the efforts to deploy the stent i believe the flexor was broken.Pushing the button in the recapture position is unlikely to have caused any issue.Confirmation of complaint: complaint is confirmed based on visual and functional inspection.Summary of investigation: according to the customer the catheter separated during deployment.Confirmed quantity of 1 device, confirmed used.Investigation findings conclude a possible root cause of the broken flexor breaking is most likely tortuous anatomy/tight stricture.The red marker was found to be at the 9th dimpling in the lab evaluation, this means the user was attempting to deploy the stent.In the efforts to deploy the stent i believe the flexor was broken.Pushing the button in the recapture position is unlikely to have caused any issue.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on visual and functional inspection.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 26jan2023.

• 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: 14495369
• MDR Text Key: 294500060
• Report Number: 3001845648-2022-00305
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)230714(10)C1850270
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1850270
• 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: 04/26/2022
• Event Location: Hospital
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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