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

Catalog Number EVO-25-30-10-C

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

It was originally indicated that the device involved in this complaint was being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.As the device has not yet been returned for evaluation; the cause of this complaint could not be conclusively determined.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-25-30-10-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 (b)(4).A review of the manufacturing records for this evolution device of lot c1182866 revealed no discrepancies that could have contributed to this complaint issue.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

It was reported by the user that the stent did not deploy completely.Replace new device to finish the procedure.

Manufacturer Narrative

Device evaluation confirmed the stent was received fully retracted in the sheath of the introduction system.The investigation confirms that partial stent deployment was not possible, reference investigation below.This complaint reportability has been re-assessed and no longer meeting the reporting criteria of an fda mdr malfunction report.Fda mdr precedence not applicable as no partial stent deployment occurred as per the investigation conclusions.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ mdr report.On evaluation of the returned device, it was noted that no lockwire was returned and the stent was fully retracted into the sheath.Note: stent cannot be retracted into the sheath after lockwire is removed.The flexor was rough, damaged and kinked.Deployment was not possible; the handle was opened during the lab to reveal that the flexor was broken.The customer complaint was considered as the flexor was broken.Prior to distribution all evo-25-30-10-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 (b)(4).There is no evidence to suggest that this issue affects the entire lot # c1182866; upon review of complaints this failure mode has not occurred previously with this lot # c1182866.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 follow up report is being submitted to cancel the initial report.Due to the receipt of the device this event has been re-assessed and no longer meeting the reporting criteria of an fda mdr malfunction report.This event was conservatively reported based on malfunction precedence for this device family for the issue of "deployment issue resulting in the exposed stent being removed from the patient".No adverse effects to the patient have been reported as occurring.Device evaluation confirmed the stent was received fully retracted in the sheath of the introduction system.The investigation confirms that partial stent deployment was not possible.(reference investigation for full details).Fda mdr precedence not applicable as no partial stent deployment occurred as per the investigation conclusions.Initial description submitted as follows:it was reported by the user that the stent did not deploy completely.Replace new device to finish the 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
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6105377
• MDR Text Key: 59978140
• Report Number: 3001845648-2016-00329
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)171215(10)C1182866
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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 Catalogue Number: EVO-25-30-10-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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
• Patient Age: 52 YR