MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number EVO-22-27-9-D

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2016

Event Type  Injury  

Manufacturer Narrative

As the device has not yet been returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.Prior to distribution all evo-22-27-9-d 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-22-27-9-d of lot number c1265403 did not reveal any discrepancies that could have contributed to this issue.From the information provided, 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 user inserted the delivery system into jf-260v first but decided to change the endoscope due to poor visibility.He then removed the delivery system from jf-260v and found the white tip was detached and lodged at the endoscope's accessory channel.He removed the lodged white tip from the endoscope and put it back to the tip of the delivery system by hand.Then he inserted the delivery system into another endoscope gif-2t240 and the stent was placed at the target site without problem, but the white tip got detached again and dropped in the duodenum.The dropped white tip was successfully removed from the patient's body using a snare and the procedure was completed.

Manufacturer Narrative

It was originally indicated that the device involved in this complaint was not being returned to cook ireland for evaluation; however the device was returned on 25-jan-2017 and evaluated on 26-jan-2017.Device was returned with the white tip detached from the device.The safety wire had been pulled.There is a kink evident in the clear section of the sheath.The user had commented: ¿it could have been glued poorly.Please investigate the cause.¿ it was confirmed during the evaluation that there was evidence of roughening and sufficient glue on the tip of the polyimide where the white tip gets attached.The (b)(4) r & d engineer also commented that the white tip to polyimide joint is proof loaded at greater than 15n.The device actuated ok and was fully functional.The stent was deployed and was ok.The white tip was cut open and placed on the microscope.It was clearly evident that the blood had stuck to where the sufficient glue was.Following device evaluation the (b)(4) r & d engineer had the following query: ¿in relation to the first time the user inserted the delivery system into the scope ~ did they actuate the device at any point prior to the delivery system being removed from the scope.¿ the following response was received: ¿the sales rep told me that the user changed the endoscope before actuating the device because he couldn't get a good sight with that endoscope.¿ a definitive cause for the reported issue was unable to be determined as the actual use conditions could not be duplicated in the laboratory setting.However, in terms of the endoscopes influence on this complaint, the (b)(4) r & d engineer commented that the first scope (jf-260v) is a side viewing scope that incorporates an elevator.If the elevator was engaged, this could have had an influence on the complaint.These stents are typically deployed using forward viewing scopes such as gif-2t240.Following device evaluation and consultation with engineering in relation to this complaint, a second failure mode was identified and therefore a second pr was required and initiated ¿ (b)(4).The second failure mode that was identified was ¿ifu not followed - user error¿.The customer complaint was confirmed as the white tip was detached from the device.Prior to distribution all evo-22-27-9-d 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 (b)(4).A review of the manufacturing records for evo-22-27-9-d of lot number c1265403 did not reveal any discrepancies that could have contributed to this issue.From the information provided, 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 report is being submitted due to the evaluation of device involved in this event.The user inserted the delivery system into jf-260v first but decided to change the endoscope due to poor visibility.He then removed the delivery system from jf-260v and found the white tip was detached and lodged at the endoscope's accessory channel.He removed the lodged white tip from the endoscope and put it back to the tip of the delivery sytem by hand.Then he inserted the delivery sytem into another endoscope gif-2t240 and the stent was placed at the target site without problem, but the white tip got detached again and dropped in the duodenum.The dropped white tip was successfully removed from the patient's body using a snare and the procedure was completeted.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: 6269773
• MDR Text Key: 65517379
• Report Number: 3001845648-2017-00023
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)180824(10)C1265403
• Combination Product (y/n): N
• PMA/PMN Number: K101530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EVO-22-27-9-D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/26/2016
• Event Location: Hospital
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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