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

Model Number G48027

Device Problem Delivery System Failure (2905)

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

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # "k101530 and k163468".(b)(4).The customer reported the following complaint issue: ¿stent didn't release from the carrier system.Contact in dept is dr.(b)(6)¿ the following additional information was provided: ¿yes it was in contact with the patient did the stent partially deploy within the patient? no.Was there any issue noted with the handle or sound when the stent was deploying? no.Did the patient require intervention or any additional procedures? no.They´ve noticed the break during the release of the stent.The stricture could be passed without any problem.Olympus duodenoscope with sideview optic (190).The stricture was 7 cm/ pylorus & duodenum.There was no problem advancing the wire guide.No resistance noticed with the product.The mark was visible the entire time.Unfortunately the customer can´t deliver any pictures.¿ it was confirmed that the procedure was finished ¿with a new evolution from the consignment.¿ one x evo-22-27-12-d was returned to cirl for evaluation.Upon evaluation of the returned device, it was noted that there was no stent exposure from the sheath on return of the device.The lockwire was in place and the red shuttle deployment marker was towards the back half of the handle.There was damage noted to the introducer.The flexor was broken at the coiled section beyond the transition of the blue and clear material.The device operated correctly during lab evaluation and the inner catheter was working correctly.Actuation was possible up to the point that the flexor was broken.The customer complaint was confirmed as the failure was verified in lab; the flexor was broken at the coiled section.As usage conditions cannot be replicated in the laboratory setting, a definitive root cause for this complaint could not be conclusively determined.However, it is possible that the side viewing scope used could have caused the damage, there may have been excessive use of the elevator.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.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 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #; upon review of complaints this failure mode has not occurred previously with this lot #.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".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.From the information provided, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".Stent didn't release from the carrier system.Contact in dept is dr.(b)(6).

• 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: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7133404
• MDR Text Key: 96039586
• Report Number: 3001845648-2017-00620
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)190120(10)C1317462
• Combination Product (y/n): N
• 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: 11/29/2017

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?: Yes
• Device Operator: No Information
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-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: 12/20/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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