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

Model Number	G48032
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fcg kit, needle, biopsy.(b)(4).
Event or Problem Description
According to the initial reporter: "endoscopy was performed, a tumor is marked and then the wire guide was installed through the scope.With rx the stent is advanced through the wire guide and placed in position.The physician begins to deploy the stent smoothly until the red button reaches the "point of no return" the stylet was completely removed and the delivery continues until the end.At the time of removing the deployment system the stent wasn´t separate and it started to came together being trapped finally in the upper esophageal sphincter, the physician removed with a alligator jaw forceps.Then a brand new stent was installed without any problem.".

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10918256
• Report Number: 3005580113-2020-00446
• Device Sequence Number: 2478360
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)210205(10)C1582798
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2020
• Report Date (Section F): 11/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1582798
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 65