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

Model Number G48028

Device Problem Break (1069)

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

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported to customer relations: "after traversing stricture with wire guide stent was placed over wireguide and placed down scope, after stent was exiting scope it felt difficult to push, the sent was then in position but under fluoroscopic image the tip of stent appeared to be approx 5cm away from end of stent, nurse began squeezing trigger to begin to deploy, with great difficulty - then she felt and we heard a snap- unable to recapture or deploy - stent was removed from scope and it did not deploy - we used another evolution colonic stent of same size to complete procedure.".

Manufacturer Narrative

510 (k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 03 october 2018.Outer flexor was broken at shuttle cap.Documents review including ifu review: prior to distribution all evo-25-30-8-c devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl upon review of complaints, this failure mode has not occurred previously with the lot number c1328257.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1328257.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".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0052-10).Root cause review: the failure of ¿outer flexor was broken at shuttle cap" was observed in the laboratory.A possible root cause of ¿delamination of the ptfe liner of the outer sheath¿ was identified in the laboratory.It may be noted that a project was completed by product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.Summary: customer complaint confirmed as failure was verified in laboratory according to the information reported, 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

The device was evaluated on the 03-oct-18 confirming the "outer flexor was broken at shuttle cap." this fie is being reported on the fda mdr reportable reporting precedence for this device family for the issue of ¿flexor kinked/ stretched/ broke/ compressed¿.As reported to customer relations: "after traversing stricture with wire guide stent was placed over wireguide and placed down scope, after stent was exiting scope it felt difficult to push, the sent was then in position but under fluroscopic image the tip of stent appeared to be approx 5cm away from end of stent, nurse began squeezing trigger to begin to deploy, with great difficulty - then she felt and we heard a snap- unable to recapture or deploy - stent was removed from scope and it did not deploy - we used another evolution colonic stent of same size to complete procedure.".

• 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: 8024920
• MDR Text Key: 125918760
• Report Number: 3001845648-2018-00511
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190221(10)C1328257
• 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: 10/31/2018

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 Expiration Date: 02/21/2019
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1328257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1