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 Problems Break (1069); Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

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

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

The incident meets mdr reporting criteria based on the precedence for a partially deployed stent being removed from the pt; regardless of pt outcome.The evo-22-27-12-d device involved in this complaint was not returned for eval.With the info provided, a document based investigation was carried out.The customer complaint was confirmed based on the customer testimony.As the device has not been returned and the actual use conditions could not be replicated, we cannot conclusively determine the cause of this complaint.As per cirl internal procedure, the relevant personnel are instructed to actuate the handle completely in both directions for the entire range of travel.The actuation should be smooth and consistent.There is also a cirl internal check which instructs the relevant personnel to deploy the stent approximately 50% using a manual aid and inspect the device.As per the instructions for use that accompanies this device, the user is advised of the following: "to deploy the stent, remove red safety guard from handle, then squeeze the trigger.Note each trigger squeeze will deploy the stent by an equal amount.If stent repositioning is required during deployment, it is possible to recapture stent.Note it is not possible to recapture stent after passing point of no return, indicated when red marker on top of handle has passed the point of no return indicator on handle label.To fluoroscopically monitor the point of no return, the stent can be recaptured until the point where the outer catheter radiopaque marker is aligned with the second inner catheter radiopaque marker.When point of no return has been passed, disconnect luer lock fitting and remove the safety wire completely from delivery handle.Continue deploying stent by squeezing trigger".Prior to distribution, all evo-22-27-12-d devices are subject to visual inspection and functional checks to ensure device integrity.A review of the mfg records for did reveal any discrepancies that could have contributed to this complaint issue.From the info provided there were no adverse effects to the pt.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

While deploying the stent, the deployment system broke.The stent was fully positioned and they were in the initial stage of deploying.The stent was approximately 10-15% deployed when system broke.They heard a loud snap in the handle of the deployment system and then the stent could not be deployed further.They were left there with a partially deployed stent.The dm had to break open the handle of the delivery system in order to finish deploying the stent.The stent was successfully deployed.An unintended section of the device did not remain inside the pt's body.The pt did not require any additional procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This incident meets mdr reporting criteria based on the precedence for a partially deployed stent being removed from the patient; regardless of patient outcome.This incident meets mdr reporting criteria based on the precedence for a partially deployed stent being removed from the patient; regardless of patient outcome.

Event Description

While deploying the stent, the deployment system broke.The stent was fully positioned and they were in the initial stage of deploying.The stent was approximately 10-15 % deployed when system broke.They heard a loud snap in the handle of the deployment system and then the stent could not be deployed further.They were left there with a partially deployed stent.The dm had to break open the handle of the delivery system in order to finish deploying the stent.The stent was successfully deployed.

Manufacturer Narrative

This incident meets mdr reporting criteria based on the precedence for a partially deployed stent being removed from the patient; regardless of patient outcome.This complaint is related to 1 x evo-22-27-12-d device of lot# c1104936.1 x evo-22-27-12-d device of lot# c1104936 was returned for evaluation.The handle of the device was returned dismantled.All components within the handle were present.On evaluation of the dismantled returned device, it was noted that the flexor had snapped at the shuttle cap.The stent was not returned as it was successfully deployed during the procedure.The customer complaint could be confirmed as the flexor was broken within the handle.A possible cause of this damage occurring may have been that it was a tortuous anatomy.Another possible cause could be that there was massive pressure and force may have been applied when attempting to deploy the stent.A further possible cause may be stretching because it was the flexor that broke.However, as actual use conditions could not be replicated in the laboratory we cannot conclusively determine the cause of this complaint.As per cirl internal procedure, the relevant personnel are instructed to actuate the handle completely in both directions for the entire range of travel.The actuation should be smooth and consistent.There is also a cirl internal procedure which instructs the relevant personnel to deploy the stent approximately 50% using a manual aid and inspect the device.As per the instructions for use, the user is advised of the following: "to deploy the stent, remove red safety guard from handle, then squeeze the trigger.Note each trigger squeeze will deploy the stent by an equal amount.If stent repositioning is required during deployment, it is possible to recapture stent.Note it is not possible to recapture stent after passing point of no return, indicated when red marker on top of handle has passed the point of no return indicator on handle label.To fluoroscopically monitor the point of no return, the stent can be recaptured until the point where the outer catheter radiopaque marker is aligned with the second inner catheter radiopaque marker.When point of no return has been passed, disconnect leur lock fitting and remove the safety wire completely from delivery handle.Continue deploying stent by squeezing trigger.¿ prior to distribution, all evo-22-27-12-d devices are subject to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for did not reveal any discrepancies that could have contributed to this complaint issue.From the information provided there were no adverse effects to the patient.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

(b)(4).While deploying the stent, the deployment system broke.The stent was fully positioned and they were in the initial stage of deploying.The stent was approximately 10-15 % deployed when system broke.They heard a loud snap in the handle of the deployment system and then the stent could not be deployed further.They were left there with a partially deployed stent.The dm had to break open the handle of the delivery system in order to finish deploying the stent.The stent was successfully deployed.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 4928006
• MDR Text Key: 24211420
• Report Number: 3001845648-2015-00139
• Device Sequence Number: 1
• Product Code: MUM
• 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: Physician
• Report Date: 06/18/2015,09/08/2015

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 Expiration Date: 04/28/2017
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1104936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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