MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9755RSL29A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by an edwards clinical safety officer, approximately 1 year and 8 months following implantation of a 29 mm sapien 3 ultra resilia valve in the mitral position within a sapien m3 valve system, the patient required rehospitalization.A transesophageal echocardiogram (tee) demonstrated moderate transprosthetic mitral regurgitation with a mean mitral gradient (mg) of 17 mmhg.
Additional Manufacturer Narrative
The investigation is ongoing.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 29MM
• 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: 24746338
• Report Number: 2015691-2026-13715
• Device Sequence Number: 18497431
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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
• Device Expiration Date: 06/18/2026
• Device Model Number: 9755RSL29A
• 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: 03/08/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2023
• 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: Hospitalization
• Patient Sex: Unknown