MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

Catalog Number EVO-FC-10-11-6-B

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us.Pma/510(k)# of similar device: k121430.The stent was not returned.Reference report 3001845648-2016-00274 for evaluation of the delivery system.The customer complaint is considered to be confirmed based on the customers¿ testimony and provided imaging.Prior to distribution all evo-fc-10-11-6-b devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cook (b)(4).As per the instructions for use: additional complications include that can occur in conjunction with biliary stent placement include but are not limited to: trauma to the biliary tract or duodenum; perforation; obstruction of the pancreatic duct; stent migration¿.A review of the manufacturing records for lot number c1250179 revealed no discrepancies that could have contributed to this complaint issue.There have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

It was reported that during stent placement the doctor wanted to recapture the stent which went very well.They saw the stent in papilla and the doctor asked the nurse to deploy the stent and remove the safety wire.The stent then disappeared and migrated into the bile duct.They saw the black piece of the catheter and also a piece of wire.The catheter was broken! they removed the black catheter and the white wire.They placed another fully covered boston stent.This report addresses the incident of stent migration.Reference also report 3001845648-2016-00274 for issue of catheter breakage resulting in surgical intervention.

Manufacturer Narrative

This is a follow up report while the investigation and risk assessment is still being carried out.A final report will be sent within 30 days once complete.

Event Description

This is a follow up report while the investigation and risk assessment is still being carried out.A final report will be sent within 30 days once complete.It was reported that during stent placement the doctor wanted to recapture the stent which went very well.They saw the stent in papilla and the doctor asked the nurse to deploy the stent and remove the safety wire.The stent then disappeared and migrated into the bile duct.They saw the black piece of the catheter and also a piece of wire.The catheter was broken! they removed the black catheter and the white wire.They placed another fully covered boston stent.This report addresses the incident of stent migration.Reference also report 3001845648-2016-00274 for issue of catheter breakage resulting in surgical intervention.

Manufacturer Narrative

This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us.Pma/510(k)# of similar device: k121430.On completion of the complaint investigation, it was concluded that the complaint issue was 'incorrect placement' and not 'stent migration' as originally reported, see investigation details below.No adverse effects to the patient were reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ mdr report.The following comments were provide by engineering on completion of the investigation ".The stent misplacement was due to the doctor not anticipating the change in the deployment behaviour of the second stent due to it being overlapped.If the second stent had just been a single stent i believe it would have deployed in the correct location as the doctor had hoped for." as per instruction for use that accompanies this device "testing of overlapping stents has not been completed and is not recommended".No reporting malfunction precedence exists for this complaint event for this product family.The incident occurred due to the abnormal use of the product.Investigation details: the delivery system of 1 x evo-fc-10-11-6-b of lot number c1250179 was returned to cirl for evaluation under (b)(4).As per an engineering assessment completed, while the complaint described this as 'migration', engineering would describe this as 'incorrect placement of stent'.The assessment determined this to be stent misplacement due to the doctor not anticipating the change in the deployment behaviour of a second stent due to it being overlapped.If the second stent had been a single stent it is believed that it would have deployed in the correct location as the doctor had hoped for.The customer complaint is considered to be confirmed based on the customers¿ testimony and provided imaging, however, engineering assessment has concluded the issue to be incorrect placement of stent.Prior to distribution all evo-fc-10-11-6-b devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).As per the instructions for use: "testing of overlapping stents has not been completed and is not recommended".A review of the manufacturing records for lot c1250179 revealed no discrepancies that could have contributed to this complaint issue.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted to cancel the initial reports.It was initially reported that during stent placement the doctor wanted to recapture the stent which went very well.They saw the stent in papilla and the doctor asked the nurse to deploy the stent and remove the safety wire.The stent then disappeared and migrated into the bile duct.They saw the black piece of the catheter and also a piece of wire.The catheter was broken! they removed the black catheter and the white wire.They placed another fully covered boston stent.This incident was assessed as meeting the criteria of an fda mdr report based on the device malfunction reporting precedence for this device family for the issue of "stent migration".No adverse effects to the patient have been reported as occurring.On completion of the complaint investigation, it was concluded that the complaint issue was "incorrect placement" and not "stent migration" as originally reported.The following comments were provide by engineering ".The stent misplacement was due to the doctor not anticipating the change in the deployment behaviour of the second stent due to it being overlapped.If the second stent had just been a single stent i believe it would have deployed in the correct location as the doctor had hoped for." as per the instructions for use that accompanies this device "testing of overlapping stents has not been completed and is not recommended".Based on this new information this event was re-assessed and it has been determined that this event no longer meets the reporting criteria of an fda ¿serious injury¿ report or ¿malfunction¿ mdr report.Reference also report 3001845648-2016-00274 for issue of catheter breakage resulting in surgical intervention.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• 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: 5980009
• MDR Text Key: 56025246
• Report Number: 3001845648-2016-00275
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)180707(10)C1250179
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-10-11-6-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/30/2016
• Event Location: Hospital
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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