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 Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).(b)(6).(b)(4).One x evo-25-30-8-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that there was no stent exposure from the sheath.The lockwire was in place and the red shuttle deployment marker at the back of the handle.Actuation was possible but it was not possible to deploy/retract.The handle was dismantled during lab evaluation to show that the flexor had broken at the shuttle cap.No other defects were observed.The stent was manually deployed and no defect was noted with the stent.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 root cause 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.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

During the procedure the stent did not expanded.

Manufacturer Narrative

Pma/510(k) # k163468.Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).This follow up mdr is being submitted due to corrections.1 x evo-25-30-8-c of lot number c1134085 was returned to cook (b)(4) for evaluation.On evaluation of the returned device, it was noted that there was no stent exposure from the sheath.The lockwire was in place and the red shuttle deployment marker at the back of the handle.Actuation was possible but it was not possible to deploy/retract.The handle was dismantled during lab evaluation to show that the flexor had broken at the shuttle cap.No other defects were observed.The stent was manually deployed and no defect was noted with the stent.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 root cause 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 cook (b)(4).A review of the manufacturing records for this evolution device of lot c1134085 revealed no discrepancies in the manufacturing records that could have contributed to this complaint issue.It may be noted that a project (b)(4) was assigned at this time to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.There is no evidence to suggest that this issue affects the entire lot # c1134085; upon review of complaints this failure mode has not occurred previously with this lot # c1134085.The instructions for use, ifu0052-10 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 and the risk has been determined to be moderate.No immediate action is required.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 (risk assessment omitted).During the procedure the stent did not expanded.

• 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: 6844432
• MDR Text Key: 84969182
• Report Number: 3001845648-2017-00380
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)170722(10)C1134085
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K113510
• 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,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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