MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED

Device Problem Activation Failure (3270)

Patient Problem Surgery, prolonged (2177)

Event Date 02/24/2015

Event Type  Injury  

Event Description

An oesophageal stent failed to fully open at the distal end after deployment and had to be retrieved.On further inspection, the stent lasso had a small knot in the distal end which had prevented the stent from opening.A section of the device did not remain inside the pt's body.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

The exact rpn is unk.However, evolution esophageal stents (hence considered similar devices) are currently marketed in the us under the following 510 (k) #s: k093619 and k080359.The info relating to this event is currently being investigated.A f/u mdr will be submitted with the investigation conclusions.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr specialist ; 61334440
• MDR Report Key: 4641459
• MDR Text Key: 16185689
• Report Number: 3001845648-2015-00059
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2015
• Event Location: Hospital
• Date Manufacturer Received: 02/25/2015
• 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): Required Intervention