MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48028

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The device was advanced to desired position and then operator triggered the stent but failed.Operator pull the device out a bit and found out the distal end of outer sheath is broken.Reporting due to precedence: issue of ¿flexor kinked/stretched/broke/compressed" for this device family.

Manufacturer Narrative

Pma/510k number = k113510 + k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Problem statement: the device was advanced to desired position and then operator triggered the stent but failed.Operator pull the device out a bit and found out the distal end of outer sheath is broken.The following additional information was received in the complaint file: what is the reorder number of the wire guide used with this device? boston jagwire if not with the device in question, how was the procedure finished?replace another same device to finish the device what is the endoscope manufacturer and model number that was used during the procedure? olympus had dilation of the stricture been performed prior to stent placement? yes what was the diameter of the stricture at the time of stent placement (in mm)? 6mm what was the length of the stricture at the time of stent placement (in cm)? 3.5cm please describe the location in the body where the stent was to be placed.6mm was resistance encountered when advancing the wire guide through the stricture? slight resistance was resistance encountered when advancing the introducer and stent into position? slight resistance did any section of the device detach inside the patient? no.After placement, was stent position verified? if yes, please describe how.The stent was not released.After placement, was the endoscope advanced through the stent? no.Please estimate amount of time the stent was in place prior to this occurrence.Stent was not released did the patient undergo chemotherapy or radiation treatments after stent placement? no.Device evaluation: the evo-25-30-8-c device of lot number c1403815 was returned to cook ireland and evaluated on the (b)(6) 2018.Lab evaluation: upon review of the returned device, the lockwire was returned partially removed and displaced.Possibly due to removing then attempting to reload of wireguide.There was no stent exposure.The red shuttle deployment marker was at the back of the handle.Actuation was possible, showing all internal components of the device were okay, however due to the break in the flexor no deployment of retraction of the stent was possible.There is a slight kink on the peak tubing where the break is.Damage was also noted on the polyamide.Device was dismantled during the lab.Stent was manually deployed.No issues with the stent.Complaint is confirmed as the failure was verified in the laboratory.The outer sheath was broken.Following device evaluation, additional queries were sent and the following addition information was provided.1) was there any damage noted to the device before use? no.2) was any part of the stent deployed and retracted during the procedure? no.Root cause: it¿s likely the potential cause of failure is related to handling damage which damaged/weakened/kinked the wall of the outer sheath.This resulted in a buildup of pressure and the flexor breaking during the procedure.Document review: prior to distribution all evo-25-30-8-c 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 this evolution device of lot c1403815 did not show any discrepancies in the manufacturing records that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1403815; upon review of complaints this failure mode has not occurred previously with this lot # c1403815.Ifu review: 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".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.Summary: complaint is confirmed as the failure was verified in the laboratory.The outer sheath was broken.The patient did not require any additional procedures due to this occurrence.Another device was used to finish the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The device was advanced to desired position and then operator triggered the stent but failed.Operator pull the device out a bit and found out the distal end of outer sheath is broken.Reporting due to precedence: issue of ¿flexor kinked/stretched/broke/compressed" for this device family.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7425467
• MDR Text Key: 105937837
• Report Number: 3001845648-2018-00168
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190926(10)C1403815
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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 Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 68