MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9755RSL23A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the edwards field clinical specialist, during a transcarotid transcatheter aortic valve replacement procedure with a 23 mm sapien 3 ultra resilia valve, the valve was unintentionally deployed 60:40 aortic/ventricle position and an attempt was made to post dilatate due to minimal under-expansion.Following post dilation, it was observed that the valve had migrated toward the ventricle.A second valve was prepared, and an attempt was made to deploy this valve just above the previously implanted valve to prevent further migration.During advancement of the delivery system, the delivery system nosecone dislodged the first valve, resulting in migration of the valve into the left ventricle.A 22 mm balloon was advanced within the migrated valve and inflated, and an attempt was made to pull the valve back into the annulus; however, this attempt was unsuccessful.The second valve was never deployed, as it was safely removed with the delivery system.A decision was then made to proceed with an open surgical procedure to rescue the embolized valve and implant a surgical valve.The patient remained stable throughout the procedure and was reported to be intubated following the intervention.The devices were not available for return, as they were discarded.There was no perceived patient related or procedural reason for the valve migration.
Additional Manufacturer Narrative
The investigation is ongoing.This report is 2 of 2 being submitted for this complaint.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 23MM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24716751
• Report Number: 2015691-2026-13600
• Device Sequence Number: 20330880
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: 9755RSL23A
• Device Catalogue Number: 13495890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female