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 Type  malfunction  

Manufacturer Narrative

This event is reportable to the fda on the basis of the malfunction reporting precedence established for this product family for ¿deployment issue resulting in exposed stent being removed from patient with the delivery system'.This complaint is related to 1 x evo-22-27-12-d device of lot#c1133359.The complaint device was not available to be returned for evaluation.With the information provided a document based investigation was carried out.The customer complaint was confirmed based on the customer testimony.Prior to distribution, all evo-22-27-12-d 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.A review of the manufacturing records for evo-22-27-12-d device of lot number c1133359 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of instructions for use 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 were no adverse effects to the patient due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The stent partially deployed as there was a trigger malfunction.The device malfunctioned at the trigger level and would no longer deploy.A new evo-22-27-12-d device was opened and used to complete the procedure.

• 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: 5249969
• MDR Text Key: 32111490
• Report Number: 3001845648-2015-00254
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Report Date: 10/29/2015

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1