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

Model Number	G23130
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Cable bent and broken in 2 places ( stored in its secondary packaging therefore not linked to our storage conditions ) the stent was placed with an ambu duodenoscope "as per cc form": implatation of an evolution stent for intrahepatic stenosis.When the stent is released, the trigger has hard/difficult and it is blocked (sound of "clac" in the gun).Analysis of the flexor on withdrawal: kinking in many places.Lab evaluation completed on: 02 mar 2022.Visual inspection: flexor breakage observed approximately 128cm from white tip.Lock wire in place on return.Red marker at 7th dimpling on handle.Stent is partially deployed on return.Functional inspection: handle actuating fine.Unable to deploy the stent due to flexor breakage.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 general questions: at what stage of the procedure did the complaint occur? during stent placement, while removing the introducer.What endoscope type and channel size was used? ambu endoscope disposable what was the position of the elevator? open.Details of the wire guide used (diameter, type, make)? 025 inch visiglide olympus was the zip port facing upwards and slightly curved when backloading the wire guide? n/a.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.Please advise the anatomical location of the intended target site.Second duodenal.How long was the stent in the patient by the time this complaint occurred? 1 minute.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, if yes, how often was this completed? did the patient require any additional procedures as a result of this event?, no were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? the stent is ok on the examen start if yes, please specify what was observed and where on the device it was observed.Flexor ok.Stricture information: what was the length and diameter of the stricture? where was the stricture located in the body? intra hepatic was there resistance felt passing wire guide through stricture? no.Was there resistance felt passing the evolution through stricture? no.Was the stricture dilated before stent placement? n/a yes, no.Questions related to during insertion into patient was the product inspected for kinks or damage before use? yes, was resistance felt during insertion into patient?, no.Questions related to during stent placement did the product fail during stent deployment or recapture?, deployment, if other, please specify.Was the directional button pressed during use? no, before.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure?, no.Was the yellow marker kept in view during deployment? yes, are images of the device or procedure available? yes.Questions related to during introducer withdrawal are images of the device or procedure available? yes, was final stent placement confirmed using endoscopy / fluoroscopy? no.If yes, what was used? did the stent open sufficiently to allow withdrawal of introducer safely?, yes, was the safety wire fully removed before removing the delivery system? n/a, , did any part of the product snag/get caught with the stent when removing the delivery system? n/a.
Additional Manufacturer Narrative
The evo-10-11-10-b device of lot number c1850644 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.(b)(4) (3001845648-2022-00140) were opened for this device.The product returned was identified as (b)(4) however (b)(4) was cancelled and the investigation for this complaint will be completed under (b)(4) (3001845648-2022-00140).Lab evaluation the devices involved in the complaint were evaluated in the laboratory on 02nd mar 2022.In summary the following results were observed in the lab evaluation: ¿lab evaluation date: 02 mar 2022 visual inspection: flexor breakage observed approximately 128cm from white tip.Lock wire in place on return.Red marker at 7th dimpling on handle.Stent is partially deployed on return.Functional inspection: handle actuating fine.Unable to deploy the stent due to flexor breakage¿.Prior to distribution ¿evo-10-11-10-b ¿devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-10-11-6-b of lot number c1850644 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 c1850644.As per the instructions for use, ifu0056 which accompanies delivery system description and instructs the user to "the stent is mounted on an inner catheter, which accepts a.035 inch wire guide, and is constrained by an outer catheter." there is evidence to suggest that the customer did not follow the instructions for use and as per additional information received the 0.025 inch wire guide was used.Root cause review: a definitive root cause could be attributed to user error, the investigation has determined that there is evidence to suggest that the customer did not follow the instructions for use, as per additional information received the 0.025 inch wire guide was used.Summary: customer complaint is confirmed based on customer testimony.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.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: 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: 13769787
• Report Number: 3001845648-2022-00140
• Device Sequence Number: 5033159
• Product Code: FGE
• UDI-Device Identifier: 10827002231303
• UDI-Public: (01)10827002231303(17)230715(10)C1850644
• Combination Product (Y/N): N
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: G23130
• Device Catalogue Number: EVO-10-11-10-B
• Device Lot Number: C1850644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2022
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown