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

Catalog Number EVO-22-27-12-D

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

It was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.As the device has not 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-22-27-12-d 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)(6).The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".A review of the manufacturing records for the evo-22-27-12-d device of lot number c1214344 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

It was reported that the doctor was squeezing the trigger and the red tab on the top of the delivery system was moving but the stent would not deploy.The doctor ended up cutting the catheter and deploying the stent by hand.This incident meets fda mdr reporting requirements based on the conservative presumption that the stent was partially deployed when difficulty occurred and if the physician had not fully deployed it by hand it would have been removed from the patient partially deployed.There is a device malfunction reporting precedence for this device family for the issue of "deployment issue resulting in the exposed stent being removed from the patient".No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

This follow up report is being submitted to cancel the initial report.Due to the receipt of the device this event has been re-assessed as no longer meeting the reporting criteria of an fda mdr malfunction report.Initial complaint details: it was reported that the doctor was squeezing the trigger and the red tab on the top of the delivery system was moving but the stent would not deploy.The doctor ended up cutting the catheter and deploying the stent by hand.Clarification was received on this on 20 january 2017 as follows: "i met with dr.(b)(6) about the duodenal stent case involved in this product complaint.He told me that the stent was not deployed, nor did he cut the catheter.He also mentioned that while investigating why the introduction system would not deploy, he noticed that the catheter had separated from the gun mechanism." this event was conservatively reported based on malfunction precedence for this device family for the issue of "deployment issue resulting in the exposed stent being removed from the patient".No adverse effects to the patient have been reported as occurring.Based on the device evaluation ae reportability has been re-assessed.Device evaluation confirmed the catheter of the device was not cut and the stent was received fully retracted and inside the sheath.The stent could not be deployed in the laboratory environment therefore it was confirmed the complaint to be 'the device failed to deploy'.On evaluation of the returned device, it was noted that the catheter was not cut and the stent was fully retracted in the sheath.The red marker was past the point of no return.Deployment was not possible.The lockwire was in position on return of the device.The handle was opened in the lab and the flexor was observed to be broken.The stent was deployed manually and seen to be fine.The customer complaint is confirmed as the flexor was broken.Prior to distribution all evo-22-27-12-d 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 cirl.A review of the manufacturing records for the evo-22-27-12-d device of lot number c1214344 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 report.Due to the receipt of the device this event has been re-assessed as no longer meeting the reporting criteria of an fda mdr malfunction report.Initial complaint details: it was reported that the doctor was squeezing the trigger and the red tab on the top of the delivery system was moving but the stent would not deploy.The doctor ended up cutting the catheter and deploying the stent by hand.Clarification was received on this on 20 january 2017 as follows: "i met with dr.(b)(6) about the duodenal stent case involved in this product complaint.He told me that the stent was not deployed, nor did he cut the catheter.He also mentioned that while investigating why the introduction system would not deploy, he noticed that the catheter had separated from the gun mechanism." this event was conservatively reported based on malfunction precedence for this device family for the issue of "deployment issue resulting in the exposed stent being removed from the patient".No adverse effects to the patient have been reported as occurring.Based on the device evaluation ae reportability has been re-assessed.Device evaluation confirmed the catheter of the device was not cut and the stent was received fully retracted and inside the sheath.The stent could not be deployed in the laboratory environment therefore it was confirmed the complaint to be 'the device failed to deploy'.

• 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: 6089140
• MDR Text Key: 59563515
• Report Number: 3001845648-2016-00320
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)180322(10)C1214344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101530
• 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
• Report Date: 10/14/2016

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-22-27-12-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2016
• Event Location: Home
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1