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

Catalog Number EVO-20-25-12.5-E

Device Problem Difficult to Open or Close (2921)

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

Event Date 06/02/2014

Event Type  Injury  

Event Description

Doctor positioned evo stent using x-ray and deployed the stent into the correct position.The nursing staff pulled the resheathing string out with no problems.The stent did not open up at the proximal end where the lasoo is for repositioning.It was knotted up and stayed closed.The stent had to be removed from the pt.Another evo stent was opened and deployed to successfully complete the procedure.No further adverse effects to the pt are reported as occurring.

Manufacturer Narrative

Additional info provided by the customer at a later date confirmed that the lock wire was fully removed at the correct point in the procedure.There were no evo-20-25-12.5-e (evolution) devices of lot c923447 in stock at the time of the investigation.One evolution stent was returned for evaluation.It was not returned in the original device packaging and the introduction sys was not returned.It was not possible to confirm the lot number involved.The paperwork included with the returned stent indicated that it was from lot c923447.On evaluation of the device, the complaint was confirmed as the returned stent was not fully opened at the proximal end.It was noted that the green suture woven through the crowns at the proximal end of the stent had been pulled at some point (close to the knot).Evaluation of the waving of both the green and white sutures on the stent confirmed that they were woven correctly.The white suture was pulled during the lab evaluation and it was noted that the device did not function as intended as this action failed to cause the stent to close fully.The green suture was then manipulated by hand so that it was returned to its intended position with no excess/pulled material at any location.Once this was performed, the stent opened fully and it was possible to open and close the stent fully by pulling the white suture.The stent functioned as intended.The green suture was then pulled in an attempt to replicate the issue and it was possible to replicate the problem the customer reported as the stent failed to open fully.A possible cause of the stent not opening fully during use could be if the green suture was pulled during the stent loading process during the manufacture of the evo-20-25-12.5-e device.The relevant personnel have been made aware of this complaint.However, as actual use conditions cannot be replicated in the lab, we are unable to conclusively determine the cause of this complaint.A review of the incoming qual control records for the stent component involved in this complaint did not reveal any discrepancies that could have contributed to this complaint issue.Prior to distribution, evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the mfg records for evo-20-25-12.5-e of lot c923447 did not reveal any discrepancies that could have contributed to this issue.From the info provided, the pt did not experience any adverse effects due to this occurrence.This stent was removed.The procedure was completed with another stent.Complaints of this nature will continue to be monitored for any potential emerging trends.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 3536133444
• MDR Report Key: 3949686
• MDR Text Key: 18089060
• Report Number: 3001845648-2014-00113
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/04/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C923447
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/06/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2013
• 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
• Patient Outcome(s): Required Intervention