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

Model Number G48038

Device Problems Premature Activation (1484); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  Injury  

Event Description

User felt the trigger is too tight to pull during stent deployment, and the trigger is to its limit while the stent still cannot be released.User called sales rep.On how to handle such situation who suggested to pull the stent retrieve button to retrieve the stent so that to reposition the release location.User cannot pull the retrieve button, and then user pulled both trigger and retrieve button several times while the stent suddenly released unexpectly in a wrong position.Then patient was back to emergency room and a surgical consultation was organized due to the situation.An emergency operation is conducted.

Manufacturer Narrative

Pma/510(k) # = k163468.The investigation is in progress and a follow up mdr will be submitted.

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 device evaluated on 09-dec-2021; "proximal flexor kinked.Handle actuating fine for deployment and recapture".

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Pma/510(k) # = k163468.Device evaluation: 1 unit of evo-25-30-10-c lot# c1787736 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 09 dec 2021.On evaluation of the device it was observed that the flexor was proximally kinked.Stent was not returned.Handle was actuating fine for deployment and recapture.Lock wire returned separately.Document review including ifu review: prior to distribution evo-25-30-10-c devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-25-30-10-c of lot number c1787736 did not reveal any discrepancies that could have contributed to this complaint issue.There was a gen-130 (sheath/flexor delamination) nc associated with this lot that is deemed to have no impact to this complaint.The review of relevant manufacturing records, confirms the failure mode has or has not previously occurred with the current lot number.Based on the information available to date, there is or there is no evidence to suggest that there are any manufacturing issues associated with lot number c1787736.The instructions for use ifu0052 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is not sufficient evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.Although the customer indicated that there was no resistance felt while deploying the device a possible root cause could be attributed to torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor kinking.The pressure build-up of attempting to deploy with a kinked flexor would have been felt through trigger resistance described by the customer.Continued attempts to deploy the stent, despite the trigger resistance, while the flexor was kinked may have led to the premature deployment of the stent.As per engineering input "the built up force on the outer sheath could have released at once and produced premature deployment".Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, an emergency operation was required.Details of the emergency operation are unknown.Complaints of this nature will continue to be monitored for potential 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12951595
• MDR Text Key: 281844351
• Report Number: 3001845648-2021-00835
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)221218(10)C1787736
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1787736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/09/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 11/09/2021
• Supplement Dates FDA Received: 01/06/2022; 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male