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

Model Number G48032

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Fcg kit, needle, biopsy.(b)(4).

Event 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
• MDR Text Key: 218727360
• Report Number: 3005580113-2020-00446
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)210205(10)C1582798
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020,11/30/2020

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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2020
• Date Device Manufactured: 02/05/2019
• 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
• Patient Age: 74 YR
• Patient Weight: 65