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

Model Number	G48033
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was deploying 15cm esophageal evolution partially covered metal stent,after deployment when doctor pulled the delivery device the proximal part of the stent bend inside the stent.Doctor removed the stent with the help of the rat tooth forcep and deployed another stent.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to additional information being received on 16-aug-2022.Doctor was deploying 15cm esophageal evolution partially covered metal stent,after deployment when doctor pulled the delivery device the proximal part of the stent bend inside the stent.Doctor removed the stent with the help of the rat tooth forcep and deployed another stent.Na.16thaug2022(sm) : query reply : 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 ans: while removing the introducer.2.What endoscope type and channel size was used? ans: n/a 3.What was the position of the elevator? n/a, open, closed ans: n/a 4.Details of the wire guide used (diameter, type, make)? ans: acrobat o.35 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, yes, no ans: n/a 6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? n/a, yes, no ans: yea.7.Please advise the anatomical location of the intended target site.Ans: esophagus 8.How long was the stent in the patient by the time this complaint occurred? ans: immediate 9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a, yes, no ans: n/a 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 ans: no.12.What intervention (if any) was required? ans: n/a 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 ans: same procedure 14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no ans: 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? ans: 9cm length 2.Where was the stricture located in the body? ans: mid esophagus 3.Was there resistance felt passing wire guide through stricture? n/a, yes, no ans: no.4.Was there resistance felt passing the evolution through stricture? n/a, yes, no ans: no.5.Was the stricture dilated before stent placement? n/a yes, no ans: yes.Questions related to during insertion into patient 1.Was the product inspected for kinks or damage before use? n/a, yes, no ans: no.2.Was resistance felt during insertion into patient? n/a, yes, no ans: 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 ans: other 2.If other, please specify ans: technician forgot to remove the stylet.3.Was the directional button pressed during use? n/a, yes, no ans: yes 4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a, yes, no ans: yes 5.Was the yellow marker kept in view during deployment? n/a, yes, no ans: n/a 6.Are images of the device or procedure available? n/a, yes, no] ans: no.Questions related to during introducer withdrawal 1.Are images of the device or procedure available? n/a, yes, no ans: no.2.Was final stent placement confirmed using endoscopy / fluoroscopy? n/a, yes, no ans: yes 3.If yes, what was used? ans: fluoroscopy 4.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a, yes, no ans: yes 5.Was the safety wire fully removed before removing the delivery system? n/a, yes, no ans; no.6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a, yes, no ans: n/a.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Doctor was deploying 15cm esophageal evolution partially covered metal stent,after deployment when doctor pulled the delivery device the proximal part of the stent bend inside the stent.Doctor removed the stent with the help of the rat tooth forcep and deployed another stent.Additional information received on 16-aug-2022.Technician forgot to remove the stylet.No impact to ae assessments.Supplemental report scheduled.Lab evaluation completed on 15-sep-2022.No impact to ae assessment.Supplemental report scheduled.Lot number c1819204 on package matches lot on trackwise.Visual inspection: lock wire not returned, stent returned separately intact, proximal end of delivery system broken 27.5cm from delivery tip( flexor extremely damaged on returned and broke during decon).
Event or Problem Description
Supplemental follow-up report is being submitted due to the completion of the investigation on 02-mar-2023 and an update to the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k162717.Device evaluation: user/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The device evaluation was completed for the evo-20-25-10-e device of lot c1819204 on the 15th sep 2022.On evaluation of the device the lock wire was not returned.The stent was returned separate, intact.The proximal end of the system was broken approx.27.5cm from the delivery tip.Flexor was extremely damaged on return and broke during decontamination of the device.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1819204 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label the instructions for use, ifu0061 which accompanies this device, states ¿when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port.There is 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: definitive root cause was established.The user has not complied with the requirements of the ifu and/label.According to the information available the customer did not pull the safety wire to release the stent.Failure to remove the safety wire will cause the stent to bend proximally.Summary of investigation: according to the customer the stent bent inside the stent confirmed quantity of 1 device, confirmed used.According to the initial report the patients outcome is unknown.Investigation findings conclude a definitive root cause was established.The user had not complied with the requirements of the ifu with respect to the intended use of the device.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: 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: 15224371
• Report Number: 3001845648-2022-00525
• Device Sequence Number: 20242532
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)230413(10)C1819204
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1819204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 07/19/2022; 07/19/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/14/2022; 10/13/2022; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male