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

Model Number G48028

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On evaluation of the returned device, it was noted that the stent was fully retracted into the sheath on return.The flexor was kinked at the handle.The lockwire was in place on return and the red shuttle deployment marker was less than half way back the handle.The handle was dismantled in the lab to show that the flexor had broken at the shuttle cap.The stent was manually deployed and was fine.The customer complaint was confirmed as the flexor was broken at the shuttle cap.As usage condition cannot be replicated within the laboratory setting, a definitive cannot be conclusively determined.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 (b)(4).There is no evidence to suggest that this issue effects the entire lot # c1280134; upon review of complaints this failure mode has not occurred previously with this lot # c1280134.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

This report forms part of a retrospective review of open complaints for a new malfunction precedence for this device family.The physician placed the wireguide into the colon of the patient and positioned the colonic stent across the stenosis.He verified the directional button was completely pressed and in the deployment position and he started to pull the trigger, the stent did not move and after 4 complete pulls of the trigger the physician heard a strong noise coming from the handle, then the trigger started to oppose no resistance like it was not working anymore.The physician confirmed with x-ray that the stent did not even start to deploy, he tried to change the orientation of the directional button and pull again the trigger 5 times without any result, the stent did not move.He removed without any problems the stent and he finished the procedure with another colonic stent (not from cook).

Manufacturer Narrative

Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Exemption number: e2016031 (b)(4).Importer site establishment registration number: (b)(4).1 x evo-25-30-8-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the stent was fully retracted into the sheath on return.The flexor was kinked at the handle.The lockwire was in place on return and the red shuttle deployment marker was less than half way back the handle.The handle was dismantled in the lab to show that the flexor had broken at the shuttle cap.The stent was manually deployed and was fine.The customer complaint was confirmed as the flexor was broken at the shuttle cap.As usage condition cannot be replicated within the laboratory setting, a definitive cannot be conclusively determined.A possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.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.There were no other discrepancies in the manufacturing records that could have contributed to this complaint issue.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".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

A follow up mdr is being submitted to include a possible root cause of the complaint event.The physician placed the wireguide into the colon of the patient and positioned the colonic stent across the stenosis.He verified the directional button was completely pressed and in the deployment position and he started to pull the trigger, the stent did not move and after 4 complete pulls of the trigger the physician heard a strong noise coming from the handle, then the trigger started to oppose no resistance like it was not working anymore.The physician confirmed with x-ray that the stent did not even start to deploy, he tried to change the orientation of the directional button and pull again the trigger 5 times without any result, the stent did not move.He removed without any problems the stent and he finished the procedure with another colonic stent (not from cook).

Manufacturer Narrative

(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).This is report is being submitted due to correction.1 x evo-25-30-8-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the stent was fully retracted into the sheath on return.The flexor was kinked at the handle.The lockwire was in place on return and the red shuttle deployment marker was less than half way back the handle.The handle was dismantled in the lab to show that the flexor had broken at the shuttle cap.The stent was manually deployed and was fine.The customer complaint was confirmed as the flexor was broken at the shuttle cap.As usage condition cannot be replicated within the laboratory setting, a definitive cannot be conclusively determined.A possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.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 c1280134 revealed 2 devices were scrapped one under a non conformance for ¿bunching of flexor¿ and one under a non conformance for ¿delamination of flexor¿.As per manufacturing process, the flexor sub-assemblies would have been scrapped.The non conformances would therefore not have an impact on this complaint.One device was reworked under a non conformance form for ¿sheath/flexor out of spec¿.This has been explained by production supervisor as follows: ¿as the issue was detected in step 1 of the process in prd0308, the material used could be discarded and another piece used.¿ there were no other discrepancies in the manufacturing records that could have contributed to this complaint issue.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".From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Quality engineering assessed the complaint as per qsi0413 and the risk has been determined to be moderate (ref.D00060859 rev 012).No immediate action is required (re: d00060859 rev 012 (flexor kinked/stretched/broke) - moderate risk).Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted due to corrections.The physician placed the wireguide into the colon of the patient and positioned the colonic stent across the stenosis.He verified the directional button was completely pressed and in the deployment position and he started to pull the trigger, the stent did not move and after 4 complete pulls of the trigger the physician heard a strong noise coming from the handle, then the trigger started to oppose no resistance like it was not working anymore.The physician confirmed with x-ray that the stent did not even start to deploy, he tried to change the orientation of the directional button and pull again the trigger 5 times without any result, the stent did not move.He removed without any problems the stent and he finished the procedure with another colonic stent (not from cook).

Event Description

This follow up mdr is being submitted due to corrections.The physician placed the wireguide into the colon of the patient and positioned the colonic stent across the stenosis.He verified the directional button was completely pressed and in the deployment position and he started to pull the trigger, the stent did not move and after 4 complete pulls of the trigger the physician heard a strong noise coming from the handle, then the trigger started to oppose no resistance like it was not working anymore.The physician confirmed with x-ray that the stent did not even start to deploy, he tried to change the orientation of the directional button and pull again the trigger 5 times without any result, the stent did not move.He removed without any problems the stent and he finished the procedure with another colonic stent (not from cook).

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to (b)(4).Importer site establishment registration number: (b)(4).This is report is being submitted due to correction.It may be noted that a project ire0045-k has been assigned to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.

• 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: 6716968
• MDR Text Key: 80285351
• Report Number: 3001845648-2017-00275
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)181006(10)C1280134
• Combination Product (y/n): N
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• 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: 07/17/2017
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1