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

Catalog Number EVO-20-25-15-E

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is reportable on the basis of the reporting precedence established for this product family for 'development issue resulting in exposed stent being removed from pt with the delivery system' regardless of the pt outcome.This complaint is in relation to an evo-20-25-15-e device of lot number c994501.The evo-20-25-15-e device involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was carried out.The customer complaint was confirmed based on the customer testimony.As the device was not returned for evaluation it is not possible to determine the root cause of the issue the user experienced.However, as per the district manager's comments".They didn't give it enough time for the stent to open up and allow introducer to come out without pulling the stent as well.A review of the manufacturing records for evo-20-25-15-e device of lot number c994501 did not reveal any discrepancies which could have contributed to this complaint issue.As per cl rl internal procedure, the relevant personnel are instructed to actuate the handle completely in both directions for the entire range of travel.The actuation should be smooth and consistent.There is also a girl internal procedure which instructs the relevant personnel to deploy the stent back out of the outer sheath approximately 50%.As per the instructions for use, the user is advised of the following:" confirm desired stent position fluoroscopically and deploy stent by removing red safety guard from the handle.Continue deploying stent by squeezing trigger.Note: each trigger squeeze will deploy stent by an equal amount.If stent repositioning is required during deployment, it is possible to recapture stent.Note it is not possible to recapture stent after passing point of no return, indicated when red marker on top of introducer has passed the point of no return indicator on handle." prior to distribution all evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.Information provided indicates that 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 Description

The stent was being placed in a pt with esophageal cancer; tight stricture.After they disconnected the stent from the wire, the doctor pulled the introducer out and the stent was removed with introducer.They used a new stent to complete the procedure successfully.A section of the device did not remain inside the pt's body.The pt did not require any add'l procedures due to this occurrence.The pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This complaint is reportable on the basis of the reporting precedence established for this product family for ¿deployment issue resulting in exposed stent being removed from patient with the delivery system' regardless of the patient outcome.This complaint is reportable on the basis of the reporting precedence established for this product family for ¿deployment issue resulting in exposed stent being removed from patient with the delivery system' regardless of the patient outcome.

Event Description

The stent was being placed in a patient with esophageal cancer; tight stricture.After they disconnected the stent from the wire, the doctor pulled the introducer out and the stent was removed with introducer.They used a new stent to complete the procedure successfully.

Manufacturer Narrative

This complaint is reportable on the basis of the reporting precedence established for this product family for ¿deployment issue resulting in exposed stent being removed from patient with the delivery system' regardless of the patient outcome.This complaint is in relation to an evo-20-25-15-e device of lot number c994501.One x evo-20-25-15-e device of unknown lot # was returned for evaluation.On evaluation of the returned device, the stent was returned deployed and completely detached from the introducer.Displacement of the inner sutures was observed.Evaluation of the weaving of the suture confirmed that it was woven correctly.There was a knot present near the lasso loop.It was noted that there was a bend present on the introducer.It is unknown if this damage occurred during the procedure or during transportation whilst returning the device.The lock wire was not returned with the device.The customer complaint was confirmed based on the customers testimony and the displacement of the inner sutures of the returned stent.The following comment was provided by the district manager: "the stricture was very tight and instead of giving the stent a few minutes to open a little larger, they didn't give it enough time for the stent to open up and allow introducer to come out without pulling the stent as well." the district manager is providing an in-service to the customer.As actual use conditions cannot be replicated in the laboratory we cannot conclusively determine the cause of this complaint.A review of the manufacturing records for evo-20-25-15-e device of lot number c994501 did not reveal any discrepancies which could have contributed to this complaint issue.As per (b)(4) internal procedure, the relevant personnel are instructed to actuate the handle completely in both directions for the entire range of travel.The actuation should be smooth and consistent.There is also a (b)(4) internal procedure which instructs the relevant personnel to deploy the stent back out of the outer sheath approximately 50%.As per the instructions for use, the user is advised of the following: "confirm desired stent position fluoroscopically and deploy stent by removing red safety guard from the handle.Continue deploying stent by squeezing trigger.Note: each trigger squeeze will deploy stent by an equal amount.If stent repositioning is required during deployment, it is possible to recapture stent.Note it is not possible to recapture stent after passing point of no return, indicated when red marker on top of introducer has passed the point of no return indicator on handle.¿ prior to distribution all evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.Information provided indicates that 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 Description

This follow-up mdr is being submitted to provide details of the investigation conclusion.The stent was being placed in a patient with esophageal cancer; tight stricture.After they disconnected the stent from the wire, the doctor pulled the introducer out and the stent was removed with introducer.They used a new stent to complete the procedure successfully.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 4924625
• MDR Text Key: 22996786
• Report Number: 3001845648-2015-00140
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 06/22/2015,09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2016
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C994501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2015
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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