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

Model Number	G48031
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: esw prosthesis, esophageal.
Event or Problem Description
As reported by the initial reporter, "endoscopy was performed, the doctor performed a esophageal dilation with hercules balloon until 15mm, then the tumor is marked and savary wire guide was installed.With rx the stent is advanced through the wire guide and placed in position.The physician begins to deploy the stent 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 from them so the doctor pushed the button and recaptures about 4cm trying to release the stent but nothing happened, a second attempt is made to release it but it still attached to deployment system, the doctor moves all the system and finally the stent was released but not in place, with alligator jaw forceps was repositioned.".

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10945526
• Report Number: 3005580113-2020-00453
• Device Sequence Number: 14058294
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)220214(10)C1708721
• 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): 12/03/2020
• Report Date (Section F): 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
• Operator of Device: No Information
• Device Expiration Date: 02/14/2022
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1708721
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2020
• 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: 82 YR
• Patient Weight: 52