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

Catalog Number EVO-FC-R-18-23-10-E

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

Product bent in oesophagus and was unable to deploy."as per cc form": the stent introducer was placed over the wire guide into the patients mouth, resistance was felt and the system kinked and would not deploy.This happened with 2 stents patient outcome : 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 patient/event info - notes: 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 when the stent was being introduced into the oesophagus 2.What endoscope type and channel size was used? olympus gastroscope 3.What was the position of the elevator? n/a, open, closed na 4.Details of the wire guide used (diameter, type, make)? boston super stiff 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, yes, no na 6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? n/a, yes, no yes, mouth/oesophagus 7.Please advise the anatomical location of the intended target site.Oesophagus 8.How long was the stent in the patient by the time this complaint occurred? 1cm approx.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, yes, no na 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 no 12.What intervention (if any) was required? na 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 na 14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no 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? na 2.Where was the stricture located in the body? upper oesophagus 3.Was there resistance felt passing wire guide through stricture? n/a, yes, no no 4.Was there resistance felt passing the evolution through stricture? n/a, yes, no yes 5.Was the stricture dilated before stent placement? n/a yes, no no questions related to during insertion into patient 1.Was the product inspected for kinks or damage before use? n/a, yes, no yes 2.Was resistance felt during insertion into patient? n/a, yes, no yes 3.If yes, at what point? upper oesophagus questions related to during stent placement 1.Did the product fail during stent deployment or recapture? n/a, deployment, recapture, other deployment 2.If other, please specify 3.Was the directional button pressed during use? n/a, yes, no 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 no 5.Was the yellow marker kept in view during deployment? n/a, yes, no na 6.Are images of the device or procedure available? n/a, yes, no] no questions related to during introducer withdrawal 1.Are images of the device or procedure available? n/a, yes, no no 2.Was final stent placement confirmed using endoscopy / fluoroscopy? n/a, yes, no na 3.If yes, what was used? 4.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a, yes, no no 5.Was the safety wire fully removed before removing the delivery system? n/a, yes, no no 6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a, yes, no no questions related to during stent repositioning/removal (for evo-fc & evo-pc devices) 1.What instrument was used for stent repositioning / removal? forceps, snare, other na 2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? n/a, yes, no advancement 4.If yes, please when this was felt? advancement or deployment 5.How did the physician deal with this resistance? removed x 2 stents.Third stent worked 6.Was the lasso (suture) loop used during repositioning na.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

This supplemental report is being submitted due to completion of the lab evaluation on 04-apr-2023.

Manufacturer Narrative

Device evaluation: this file is related to pr (b)(4).The evo-fc-r-18-23-10-e device of lot number c1892304 involved in this complaint was returned for evaluation, without its original packaging.With the information provided, a physical examination and document-based investigation was conducted.The devices involved in the complaint were evaluated in the laboratory on 04th april 2023.The returned device lab findings and observations can be referred through the attached file.On evaluation of the devices the following was observed: visual inspection: red safety tab is in place.Directional button in deployment position.Red marker at first dimple.Safety wire still in place.Flexor slightly kinked approx.16.5cm from white tip.Functional inspection: handle actuating fine for deployment and recapture.Stent deployed fully with no issue.Safety wire removed with no issue.Stent deployed intact.Manufacturing records: prior to distribution, all evo-fc-r-18-23-10-e devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-fc-r-18-23-10-e of lot number c1892304 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred with lot number c1892304.Instructions for use and/label: the notes section of the instructions for use, ifu0067, which accompanies this device instructs the user to inspect the device prior to 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.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.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 the torturous patient anatomy.As per additional information received there was resistance encountered during advancement and there was a resistance felt passing through the stricture, causing a build-up of pressure and resulting in outer sheath bend and causing issue reported.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, product bent in oesophagus and was unable to deploy.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a possible root cause could be attributed to the torturous patient anatomy, causing a build-up of pressure and resulting in outer sheath bend and causing issue reported.Complaint is confirmed based on visual and/or functional inspection.

Event Description

This supplemental report is being submitted due to completion of the investigation on the 04-aug-2023.

• Brand Name: EVOLUTION® ESOPHAGEAL 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: 16633947
• MDR Text Key: 312496815
• Report Number: 3001845648-2023-00179
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551685
• UDI-Public: (01)10827002551685(17)231201(10)C1892304
• 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,Followup
• Report Date: 08/04/2023

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: 12/01/2023
• Device Catalogue Number: EVO-FC-R-18-23-10-E
• Device Lot Number: C1892304
• 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: 02/20/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 02/22/2023; 02/22/2023
• Supplement Dates FDA Received: 05/03/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1