MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number EVO-22-27-12-D

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested, however no further information has been received to date.It was indicated that the device involved in this complaint was available to be returned for evaluation but to-date the device has not been received at cook (b)(4).As the device has not been received the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint was confirmed based on customer testimony.Prior to distribution, all evo-22-27-12-d devices are subject 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 the evo-22-27-12-d device of lot number c998632 revealed no discrepancies that could have contributed to this complaint issue.As per the instructions for use, notes section advises the user of the following: ¿if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would inhibit proper working condition, do not use." from the information provided there were no adverse effects to the patient.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

The first evo-22-27-12-d stent was placed successfully.Upon placing the second stent and removing the wire, the entire device came out with the wire; the stent never deployed.Possible break in the handle.Incident meets reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.

Manufacturer Narrative

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Initial complaint description submitted as follows: the first (b)(4) stent was placed successfully.Upon placing the second stent and removing the wire, the entire device came out with the wire; the stent never deployed.Possible break in the handle.No adverse effects to the patient were reported to have occurred due to this incident.From the complaint information provided this incident initially met reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.The device evaluation confirmed that the delivery system was returned for evaluation with no part of the stent exposed.The stent was fully retracted in the sheath.Based on the device evaluation this incident no longer meets the reporting criteria of an fda mdr report.Complaints of this nature will continue to be monitored for emerging trends.This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Initial complaint description submitted as follows: the first (b)(4) stent was placed successfully.Upon placing the second stent and removing the wire, the entire device came out with the wire; the stent never deployed.Possible break in the handle.No adverse effects to the patient were reported to have occurred due to this incident.From the complaint information provided this incident initially met reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.The device evaluation confirmed that the delivery system was returned for evaluation with no part of the stent exposed.The stent was fully retracted in the sheath.Based on the device evaluation this incident no longer meets the reporting criteria of an fda mdr report.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional mfg narrative-notes section for this justification.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: 5183663
• MDR Text Key: 29709352
• Report Number: 3001845648-2015-00213
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101530
• 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: 10/22/2015

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-22-27-12-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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