MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY CLOSED

Catalog Number EVO-20-25-15-E

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign body, removal of (2365)

Event Date 04/23/2014

Event Type  Injury  

Event Description

On removal of the evolution introduction system from the patient the stent came up the patient's oesophagus with the introduction system.The stent had to be retrieved from the patient's pharynx.The user confirmed the evolution stent was fully deployed during the procedure and the safety wire was pulled out.Another stent was placed and the procedure was successfully completed.No further adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

There was no evo-20-25-15-e device of lot c963536 in stock at the time of the investigation.The device involved in the complaint was not available to be returned for evaluation.With information provided a document based investigation was carried out.As the device was not available to be returned, the cause of the complaint could not be conclusively determined.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-15-e of lot c963536 did not reveal any discrepancies that could have contributed to this issue.Following the retrieval of the stent from the patient another stent was placed and the procedure was successfully completed.No further adverse effects to the patient have been reported as occurring.The customer complaint was confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.Quality engineering assessed the complaint and the risk has been determined to be category iii (low).

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY CLOSED
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3934762
• MDR Text Key: 21722379
• Report Number: 3001845648-2014-00107
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: 098538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2014
• 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
• Patient Outcome(s): Required Intervention