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U.S. Department of Health and Human Services

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

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COOK IRELAND EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED Back to Search Results
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".
 
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Brand Name
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
Manufacturer (Section D)
COOK IRELAND
o'halloran road
national technology park
limerick
EI 
MDR Report Key9362831
MDR Text Key167815623
Report Number3005580113-2019-00792
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2019
Distributor Facility Aware Date11/20/2019
Event Location Hospital
Date Report to Manufacturer11/22/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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