MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

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

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress and a follow up mdr will be submitted.

Event Description

User opened the package and advanced the delivery system through wire guide to desired position while found out the white tip out of sheath with the red "stafty" unremoved.User 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." 1.What is the reorder number of the wire guide used with this device? metii-35-480.2.If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with endoscope) also ask: 3.Had a sphincterotomy been performed prior to this occurrence? yes.4.Had dilation of the obstructed area been performed prior to this occurrence? yes.5.What is the endoscope manufacturer and model number that was used? olympus tjf-260v.6.Please describe the location in the body where the stent was to be placed.Common bile duct.7.Was resistance encountered when advancing the wire guide through the obstructed area? yes.8.Was resistance encountered when advancing the stent and introducer through the obstructed area? yes.9.Was the introducer advanced through the side of a previously placed stent? no.10.Please estimate amount of time the stent was in place prior to this occurrence.N/a.11.Did any section of the device detach inside the endoscope or patient? no.

Event Description

Supplemental report is being submitted due to lab evaluation being completed.

Manufacturer Narrative

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 the investigation on 27-feb-2023.

Manufacturer Narrative

Device evaluation: the evo-fc-10-11-6-b device of lot number c1822323 involved in this complaint was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation including ifu review: the device related to this occurrence underwent a laboratory evaluation on the06 jan 2022.On evaluation of the device the following was observed: visual inspection: red marker on top of the handle broken.Introducer slightly exposed/deployed on return.Functional inspection: handle actuating fine, stent deployed as intended.Lock wire removed without any issues.Handle opened and red marker observed broken, all other components were intact.Document review including ifu review: prior to distribution evo-fc-10-11-6-b devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-fc-10-11-6-b devices of c1822323 lot number did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1822323.The instructions for use ifu0062 which accompanies this device instructs the user that "to deploy stent, remove red safety guard from handle , (fig.B) then squeeze the trigger.Note: each full trigger squeeze will deploy stent b an equal amount." there is no evidence to suggest that the customer did not follow the instructions for use.Image review: no images were reviewed as no images were provided.Root cause review: 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 the user handling of the device, it is possible at some stage the user inadvertently actuated the trigger with the red safety guard attached exposing the white tip.¿the red safety guard on the trigger prevents the outer sheath from being retracted back.In this complaint the red safety guard was still present on the trigger which would prevent the outer sheath from retracting back from the tip.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.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: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• 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: 12982442
• MDR Text Key: 286156874
• Report Number: 3001845648-2021-00861
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)230421(10)C1822323
• Combination Product (y/n): N
• PMA/PMN Number: K121430
• 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: 02/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Catalogue Number: EVO-FC-10-11-6-B
• Device Lot Number: C1822323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 11/22/2021; 02/27/2023
• Supplement Dates FDA Received: 02/01/2022; 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 61 KG