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

Catalog Number EVO-25-30-6-C

Device Problem Delivery System Failure (2905)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).The customer reported the following complaint issue: "the catheter kinked at proximal end and the sheath came off.The entire system was removed and another device was used to complete the procedure." the following additional information has been requested but not yet provided: ¿as previously requested in last mail, it is important that we know the lot number, also 1) are images of the device available for review? 2) could an indication be given of which part of the device kinked? 3) at what point in the procedure did this occur? during insertion/deployment.Any more additional information that can be provided would be of benefit.¿ the device involved in this complaint was not available for return to cook ireland for evaluation.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Additional information has been requested to help identify a possible cause.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.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.As the lot number was not provided, a review of manufacturing instructions could not be complete.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.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

Initial mdr is being submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".The catheter kinked at proximal end and the sheath came off.The entire system was removed and another device was used to complete the procedure.

Event Description

Follow up report submitted to update investigation details with a potential root cause.Mdr is being submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".The catheter kinked at proximal end and the sheath came off.The entire system was removed and another device was used to complete the procedure.

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).Exemption number: e2016031.(b)(4).The device involved in this complaint was not available for return to cook (b)(4) for evaluation.As the device was not returned for evaluation and no images were available for review; the cause of this complaint could not be conclusively determined.However, it is engineering opinion that this would have most likely occurred with the old flexor design.The kink at the proximal end would have resulted in the flexor breaking.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.As the lot number was not provided, a review of manufacturing instructions could not be complete.However 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 cook (b)(4).On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for 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

Report is being submitted due to corrections.The catheter kinked at proximal end and the sheath came off.The entire system was removed and another device was used to complete the procedure.

Manufacturer Narrative

Pma/510(k) # k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This report is being submitted due corrections: it may be noted that a project 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: 7133403
• MDR Text Key: 96053511
• Report Number: 3001845648-2017-00617
• Device Sequence Number: 1
• Product Code: MQR
• 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
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-25-30-6-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1