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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

As indicated in the journal article "fully-covered esophageal stent migration rates in benign and malignant disease: a multicenter retrospective study", it reported that the patient required removal of the esophageal fully-covered self-expanding metal stent and replaced due to a "non-defined complications in benign indications".

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
• Manufacturer (Section D): COOK IRELAND; o'halloran road; national technology park; limerick ; EI
• MDR Report Key: 9362831
• MDR Text Key: 167815623
• Report Number: 3005580113-2019-00792
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2019
• Distributor Facility Aware Date: 11/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2019
• 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