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

Catalog Number EVO-25-30-10-C

Device Problem Material Erosion (1214)

Patient Problem Erosion (1750)

Event Type  Injury  

Event Description

After placement of the evolution device in the patient it was reported that the device eroded into the wall of the patient.Although requested no further details have been received relating to this event.No further adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Images and additional info relating to this event were requested but have not been provided to date.The device was not available to be returned for evaluation; therefore a document based investigation was carried out.The customer complaint could be confirmed based on customer testimony.As the device has not been returned the cause of the complaint could not be conclusively determined.A review of the relevant manufacturing records for evo-25-30-10-c device could not be performed as the lot number of the complaint device was not provided.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr ,specialist ; 61334440
• MDR Report Key: 4584921
• MDR Text Key: 5338423
• Report Number: 3001845648-2015-00043
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EVO-25-30-10-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Life Threatening