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

Catalog Number EVO-20-25-12.5-E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation of this incident is still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

While treating the esophageal stricture, the stylet did not come out of the evolution device once the point of no return was reached.The user pulled out the whole assembly along with the stent as the stylet could not detach from the stent.The procedure was completed by deploying another evolution esophageal stent.Incident meets reporting criteria of an fda mdr report based on the malfunction precedence established for this device family for "a deployment issue resulting in an exposed stent being removed from the patient with the delivery system." the investigation of this incident is still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.

Manufacturer Narrative

The device involved in this event has been returned for evaluation by the user and is currently in transit.As a result the investigation of this incident is still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

The device involved in this event has been returned for evaluation by the user and is currently in transit.As a result the investigation of this incident is still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.Initial event description was submitted as follows: while treating the esophageal stricture, the stylet did not come out of the evolution device once the point of no return was reached.The user pulled out the whole assembly along with the stent as the stylet could not detach from the stent.The procedure was completed by deploying another evolution esophageal stent.Incident meets reporting criteria of an fda mdr report based on the malfunction precedence established for this device family for "a deployment issue resulting in an exposed stent being removed from the patient with the delivery system.".

Manufacturer Narrative

Upon evaluation of the returned device it was noted that the safety wire was still in place in the device.The stent was returned still attached to the delivery system.The red notch on the device was well passed the point of no return.The handle was actuated and there was no issues noted with the handle.There was a kink present on the device near the peak, but the research & development engineer commented that this probably was as a result of pulling the device out of the patient.It may also have occurred in transportation whilst returning the device.The hook on the safety wire was attached to the advanced force gauge in the laboratory.It was possible to release the stent with a minimum force of 13.6n using the force gauge.No issue with the safety wire was observed.It is unknown if an attempt had been made by the user to release the safety wire.A definitive cause for the customer¿s complaint was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.The customer complaint was not confirmed as it was possible to release the stent with minimum force applied during the lab evaluation.A review of the manufacturing records for the evo-20-25-12.5-e device of lot number cf1037384 revealed no discrepancies that could have contributed to this complaint issue.Prior to distribution all evo-20-25-12.5-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.As per the instructions for use, the user is advised of the following: ¿when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port.Continue deploying stent by squeezing trigger¿.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the completion of the device evaluation and the investigation of this event.Initial event description was submitted as follows: while treating the esophageal stricture, the stylet did not come out of the evolution device once the point of no return was reached.The user pulled out the whole assembly along with the stent as the stylet could not detach from the stent.The procedure was completed by deploying another evolution esophageal stent.Incident meets reporting criteria of an fda mdr report based on the malfunction precedence established for this device family for "a deployment issue resulting in an exposed stent being removed from the patient with the delivery system.".

• 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 Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5305338
• MDR Text Key: 34584505
• Report Number: 3001845648-2015-00287
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2016

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 Catalogue Number: EVO-20-25-12.5-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2016; 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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