MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAEGEAL CONTROLL-RELEASE STENT - PARTIALLY COVERED

Catalog Number EVO-20-25-15-E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign body, removal of (2365)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

The physician was performing a scope/stent procedure and the stent did not release.The stent was deployed and the safety wire was pulled at the point of no return.When removing the delivery system it was noticed on the fluro mae that the stent was being removed with the delivery system.As a result the doctor removed the whole system.The device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence and a new stent was used.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: EVOLUTION ESOPHAEGEAL CONTROLL-RELEASE STENT - PARTIALLY COVERED
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. reg. aff. spec ; 61334440
• MDR Report Key: 4688696
• MDR Text Key: 5716633
• Report Number: 3001845648-2015-00075
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K080359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2016
• Device Catalogue Number: EVO-20-25-15-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2014
• 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