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 Foreign Body In Patient (2687)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).As the device has not been returned the cause of the 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 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-22-27-12-d of lot number c1303601 did not reveal any discrepancies that could have contributed to this issue.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

They tried to withdraw the stent but found that the outer sheath with the whole device was stuck inside patient body.They disassembled the stent and used tool clamp to withdraw the entire device from patient body.A section of the device did not remain inside the patient¿s body.Because the procedure lasted for about three hours, the patient could not tolerate further.The user arranged another procedure two days later.The final procedure was successful.

Manufacturer Narrative

(b)(4).(b)(6).The 1 x evo-22-27-12-d was returned to cirl for evaluation.Upon evaluation of the returned device, it was noted that the handle was dismantled on return of the device.The stent was partially exposed from the sheath.There was damage noted to the flexor due to pushing the device in.The flexor to shuttle cap was broken.The handle cannula buckled and broken 13 cm from the distal end of the flla.A non-cook cannula & flla were attached to the peek tubing to try deploy the stent or for more grip in trying to pull the device out of the patient.The stent was deployed during the lab and was noted to be fine.Stricture size of 0.5mm was commented on by engineer present to be ¿a very tight stricture¿.The customer complaint was confirmed as the flexor was broken.The following additional information was provided following lab evaluation: ¿sorry to response you late.I got the rely from sales rep.Thank you.Did the flexor break or did the user break it? no, they didn¿t find the flexor break.Did the cannula break as a result of the complaint or did the user break it? no, they didn¿t find cannula break.What is meant by stuck - was it that the device got stuck in the patient or that the trigger got stuck? they meant the front end of sheath of stent system was stuck in stenosis of the duodenum, not meant the trigger got stuck.¿ as discussed with cirl engineers: ¿it is assumed that the device got stuck in the tight stricture during insertion; the flexor broke due to high force created from the tight stricture which is why the stent would not deploy.They then broke the cannula when trying to pull the device out from the tight stricture.As they pulled the lockwire prematurely they would not have been able to recapture the stent if it had been deployed.¿ prior to distribution all evo-22-27-12-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.Because the procedure lasted for about three hours, the patient could not tolerate further.The user arranged another procedure two days later.The final procedure was successful.

Event Description

This follow up mdr is being submitted as the device was returned and evaluated.They tried to withdraw the stent but found that the outer sheath with the whole device was stuck inside patient body.They disassembled the stent and used tool clamp to withdraw the entire device from patient body.A section of the device did not remain inside the patient¿s body.Because the procedure lasted for about three hours, the patient could not tolerate further.The user arranged another procedure two days later.The final procedure was successful.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6601307
• MDR Text Key: 76311972
• Report Number: 3001845648-2017-00204
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)181206(10)C1303601
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 05/31/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: EVO-22-27-12-D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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
• Patient Age: 52 YR
• Patient Weight: 53