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

Model Number G48029

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information pertaining to contact office as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Problem statement: product failed/malfunction.Logged against last lot sent for this ref "as per complaint form": doctor described after advancing the stent catheter to the desire place, they begin to release the stent by squeezing the trigger of the handle but they realize that even the trigger was push the stent itself was not deploying at all.They recapture and tried two more times but it didn't work.Device evaluation: the evo-25-30-6-c device of lot number c1376642 was returned to cook (b)(4) and evaluated on the 04-april-2018 the following additional information was also received in the complaint file: what is the reorder number of the wire guide used with this device? jagwire, boston scientific if not with the device in question, how was the procedure finished? evo-25-30-10-c what is the endoscope manufacturer and model number that was used during the procedure? colonoscope ec34-i10l (they always use this scope).Had dilation of the stricture been performed prior to stent placement? no.What was the diameter of the stricture at the time of stent placement (in mm)? 6mm aprox.What was the length of the stricture at the time of stent placement (in cm)? 3cm.Please describe the location in the body where the stent was to be placed.25-30 cms from anal margin.Was resistance encountered when advancing the wire guide through the stricture? no.Was resistance encountered when advancing the introducer and stent into position? normal.Did any section of the device detach inside the patient? no.Lab evaluation: upon evaluation of the returned device, there was stent exposure.The lockwire was returned in place.The red shuttle deployment marker was at the front half of the handle.No deployment or retraction was possible.The device was dismantled during the lab.The flexor was broken in the handle, but not at the shuttle cap.This was a clean break.The stent was manually deployed in the lab.There were no issues noted with the stent.Customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken during the lab evaluation.Root cause: it¿s likely the potential cause of failure is related to handling damage which damaged/weakened/kinked the wall of the flexor.This resulted in a build up of pressure and the flexor breaking during the procedure.Document review: prior to distribution all evo-25-30-6-c 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 qc records did not reveal any issues which could have contributed to this complaint issue.Ifu review: as per 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 evidence to suggest that the user did not follow the instructions for use.Summary: customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken during the lab evaluation.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Product failed/malfunction.Logged against last lot sent for this ref."as per complaint form": doctor described after advancing the stent catheter to the desire place, they begin to release the stent by squeezing the trigger of the handle but they realize that even the trigger was push the stent itself was not deploying at all.They recapture and tried two more times but it didn't work.

• 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
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7479319
• MDR Text Key: 107753607
• Report Number: 3001845648-2018-00201
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480299
• UDI-Public: (01)10827002480299(17)190710(10)C1376642
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48029
• Device Catalogue Number: EVO-25-30-6-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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