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 Problems Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned and evaluated.This is documented in mdr 3001845648-2017-00023.Following device evaluation and consultation with engineering in relation to this complaint, a second failure mode was identified (user error) and therefore a second complaint report was required and initiated ¿ mdr 3001845648-2017-00086.The second failure mode that was identified was ¿ifu not followed - user error¿ the user ¿put it back to the tip of the delivery system by hand.¿ as per the instructions for use, notes section, the user is instructed of the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use".The user used the device knowing that the tip had detached "he removed the lodged white tip from the endoscope and put it back to the tip of the delivery system by hand." the customer complaint was confirmed as the white tip was detached from the device upon evaluation of the returned 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 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.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.So he 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.This new file is created as a result of a second failure mode (user error) being identified (from mdr 3001845648-2017-00023) as part of the device evaluation.

• 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: 6387163
• MDR Text Key: 69356869
• Report Number: 3001845648-2017-00086
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• 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: 03/08/2017
• Event Location: Hospital
• Date Manufacturer Received: 02/15/2017
• 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