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

Catalog Number EVO-FC-R-20-25-12-E

Device Problems Loss of or Failure to Bond (1068); Separation Problem (4043)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k162717.This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us therefore mdr reporting criteria applicable to this event.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Initial information received: it was not possible to completely remove the mandrel even with the prosthesis fully expanded.Following receipt of additional information on 08oct2020, the stent was fully deployed, however it was not possible to completely remove the safety wire.It was also confirmed that the device was removed from the patient using the grasping loop and a forceps (removeable stent) no adverse effects to the patient reported.Patient/event info - notes: general questions: 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).During the removal of the introducer.What endoscope type and channel size was used? gastroscope 28.What was the position of the elevator? was it opened or closed? no elevator.Details of the wire guide used (diameter, type, make)? guide wire for cpre 035x480cm cook (metii-35-480 ¿ g25686).Did any part of the stent contact the patient's anatomy when the complaint occurred? yes, it was all open/ loose.How long was the stent in the patient by the time this complaint occurred? upon withdrawal of the introducer.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? not applicable.Is the patient known to be covid-19 positive? no, she is not.Stricture information: what was the length and diameter of the stricture? stenosis of approximately 3 cm.Where was the stricture located in the body? esophagus.Was there resistance felt passing wire guide through stricture? no, there wasn¿t.Was there resistance felt passing the evolution through stricture? no, there wasn¿t.Was the stricture dilated before stent placement? no, it didn¿t.Questions related to during insertion into patient: was the product inspected for kinks or damage before use? yes, it was.Was resistance felt during insertion into patient? if yes, at what point? no, it wasn¿t.Questions related to during stent placement: did the product fail during stent deployment or recapture? implantation.Was the directional button pressed during use? yes, it was.Was any part of the stent observed in contact with the patient's anatomy at the time of failure? all.Was the yellow marker kept in view during deployment? not applicable.Are images of the device or procedure available? no, there aren¿t.Questions related to during introducer withdrawal: was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? yes.Endoscopy.Did the stent open sufficiently to allow withdrawal of introducer safely? yes, it did.Was the safety wire fully removed before removing the delivery system? no, it wasn¿t.Did any part of the product snag/get caught with the stent when removing the delivery system? yes, it did.Are images of the device or procedure available? no, there aren¿t.Questions related to during stent repositioning/removal: what instrument was used for stent repositioning / removal? forceps, snare.Forceps was the lasso (suture) loop used during repositioning.Foreign body forceps.What is meant by mandrel? is this the safety wire? yes, it is.Was the stent removed from the patient? yes, it was.Was it possible to recapture the stent? if so, was the stent able to be recaptured using the grasping loop and a forceps? yes, it was.Did the patient require intervention or additional procedures as a result of this? no, she didn¿t.Was there any injury or adverse effects caused as a result of this? no, there wasn¿t.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Component code (annex g): g04134- tube.Pma/510(k) #: k093619.Device evaluation: the evo-fc-r-20-25-12-e device of lot number c1603153 involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was conducted.From the images provided the peek tubing appears to be separated/broken.Stent is fully deployed documents review including ifu review: prior to distribution all evo-fc-r-20-25-12-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-fc-r-20-25-12-e device of lot number c1603153 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1603153 ; upon review of complaints this failure mode has not occurred previously with this lot c1603153.The instructions for use ifu (b)(4) which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." and "when stent point -of -no return has been passed, pull safety wire out of delivery handle near wire guide port to allow full stent deployment" there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.From the images provided the peek tubing appears to be separated/broken and the stent is fully deployed.A possible root cause could be attributed potentially to tortuous path, it is possible that during deployment tortuous path may have caused a build-up of pressure causing the peek tubing breakage/separation and subsequently causing the lock wire removal issues.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: complaint is confirmed based on the customers 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.

• 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
• MDR Report Key: 10683706
• MDR Text Key: 246420707
• Report Number: 3001845648-2020-00787
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)210410(10)C1603153
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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: 04/10/2021
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1603153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1