MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-FC-10-11-6-B

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User opened the package and advanced the delivery system throug wire guide to common bile duct, user press the trigger to deploy the stent by half while found out the stent was not opened as expected.User retracted the stent and found out the sheath tip brokne.User then changed to another same device to complete the procedure."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.".

Event Description

Supplemental report is being submitted due to the completion of the investigation on 07-mar-2024.

Manufacturer Narrative

Device evaluation: the evo-fc-10-11-6-b device of lot number c2038702 involved in this complaint was returned for evaluation, with its original opened packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 01 november 2023.On evaluation of the device, the following was observed: visual inspection: ¿ red safety tab not returned.¿ device returned in protective tubing.¿ red shuttle passed the point of no return.¿ directional button in deployed position.¿ flexor observed broken at clear section.¿ polyimide kinked at white tip.¿ stent returned in place.¿ safety wire not returned.Functional inspection: ¿ handle actuating fine for deployment and recapture.¿ unable to deploy stent.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: as per the instructions for use (ifu0062) notes section "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." as per the instructions for use, step 7, "to reposition the stent, the stent must first be recaptured, and the elevator must be open.Note: do not push forward on the delivery system with stent partially deployed.Push direction button on side of delivery handle to opposite side (fig.E1).Note: hold thumb on button when squeezing trigger for first time to recapture.Continue streaming trigger as required to recapture stent by desired amount¿.There is no evidence to suggest that the customer did not follow the instructions for use or product label.Image review: two images were provided by the rep showing the reported damage/breaking of the delivery system outer catheter.This damage was further noted in the lab evaluation carried out at cirl.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to torturous patient anatomy.As noted in the lab evaluation and described in the customer testimony, the flexor/outer catheter was broken upon return.It is possible that during deployment, a tortuous path combined with attempted deployment led to a build-up of pressure resulting in the flexor breaking.This break could have subsequently contributed to the stent deployment difficulty described by the customer testimony.It was noted in the lab evaluation that the polyimide was kinked at the white tip.It is possible that the torturous patient anatomy and/or the flexor break may have contributed to this polyimide kink.It is also a possibility that due to the flexor break, the delivery system could not be fully re-sheathed resulting in the polyimide being exposed upon retraction of the delivery system from the patient.This exposed retraction may have caused the polyimide kink observed.Please note that based on additional information provided by the customer and/or rep, it is unknown if any other defects were observed prior to return.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Confirmed quantity of 01x used device.Summary of investigation: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• 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: 17841472
• MDR Text Key: 324553129
• Report Number: 3001845648-2023-00747
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)250330(10)C2038702
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• 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
• Report Date: 03/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-10-11-6-B
• Device Lot Number: C2038702
• 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: 08/31/2023
• Event Location: Hospital
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 69 KG