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

Model Number G48031

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

While doing stenting case stent opened and safety wire cant able to remove.Lab evaluation 28th sep 2022.Visual inspection.Lock wire still in place.Red marker passed point of no return.Functional inspection.Actuating as intended.Pigtail lock wire removed with slight difficulty.Stent deployed fully.Patient/event info - notes: query reply: 1.While inserting stent, 2.Its over the wire devices not through the scope, 3.Na, 4.0.35, 5.Yes, 6.No, 7.Lower esophagus, 8.Na, 9.No, 10.No, 11.No, 12.Another stenting, 13.No, 14.Yes, 15.Stent not opened.Stricture information , 1.Length 4cm, 2.Lower esophagus, 3.No, 4.No, 5.Yes.During stent placement , 1.No, 2.While deploying stent not opened , 3.No, 4.No, 5.Yes, 6.Yes.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, while removing the introducer, or during stent repositioning/removal? 2.What endoscope type and channel size was used? 3.What was the position of the elevator? n/a, open, closed.4.Details of the wire guide used (diameter, type, make)? 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, yes, no.6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? n/a, yes, no.7.Please advise the anatomical location of the intended target site.8.How long was the stent in the patient by the time this complaint occurred? 9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, yes, no.10.If yes, how often was this completed? 11.Did the patient require any additional procedures as a result of this event? n/a, yes, no.12.What intervention (if any) was required? 13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day.14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.15.If yes, please specify what was observed and where on the device it was observed.Stricture information: 1.What was the length and diameter of the stricture? 2.Where was the stricture located in the body? 3.Was there resistance felt passing wire guide through stricture? n/a, yes, no.4.Was there resistance felt passing the evolution through stricture? n/a, yes, no.5.Was the stricture dilated before stent placement? n/a yes, no.Questions related to during insertion into patient.1.Was the product inspected for kinks or damage before use? n/a, yes, no.2.Was resistance felt during insertion into patient? n/a, yes, no.3.If yes, at what point? questions related to during stent placement.1.Did the product fail during stent deployment or recapture? n/a, deployment, recapture, other.2.If other, please specify.3.Was the directional button pressed during use? n/a, yes, no.4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a, yes, no.5.Was the yellow marker kept in view during deployment? n/a, yes, no.Are images of the device or procedure available? n/a, yes, no].

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the final investigation on 19-apr-23 and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation the 1xevo-20-25-10-e device of lot number c1851056 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.This file was opened to capture the safety wire becoming unable to be removed from the device to release the stent.An picture of the device was provided which shows the device with the pigtail safety wire slightly removed from the back of the device.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 28th sep 2022.On evaluation of the device the following was observed: ¿ visual inspection: lock wire still in place.Red marker passed point of no return.¿ functional inspection: actuating as intended.Pigtail lock wire removed with slight difficulty.Stent deployed fully document 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.Ifu & label review the user is instructed as per the instructions for use in step 10, ¿when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port." there is no evidence to suggest that the customer did not follow the instructions for use or the product label.Image review an image was not returned for evaluation.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the safety wire becoming trapped between the inner and outer catheter.This is possible as the stent returned for evaluation fully deployed and attached to the delivery system, the safety wire was slightly difficult to remove during the functional inspection of the evaluation.Another possible root cause could be attributed to the user not removing the safety wire at the point specified in figure 5 of the ifu which may have made it more difficult to remove the safety wire.Summary complaint is confirmed based on visual and/or functional inspection.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.From the additional information received from the customer, a replacement device was used to complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY 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: 16636123
• MDR Text Key: 312683540
• Report Number: 3001845648-2023-00184
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)230719(10)C1851056
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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: 07/19/2023
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1851056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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