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

Model Number	9755RSL20A
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral tpvr procedure with a 20mm sapien 3 ultra resilia valve, the valve was successfully implanted, and the team wanted to post dilate the valve.The team inflated the 20mm atlas to 12-14atm twice, and post angiogram showed central pulmonary regurgitation possibly due to a stuck leaflet.The team was able to confirm that 2 of the leaflets were functioning appropriately.The operator attempted to use a pigtail to dislodge the stuck leaflet but was unsuccessful.It was then determined to place a second 20mm sapien 3 ultra resilia valve.The patient underwent a valve in valve procedure.There was no pulmonary regurgitation was seen.
Additional Manufacturer Narrative
Investigation is still ongoing.
Additional Manufacturer Narrative
This supplemental report is being submitted as the event was found to be a duplicate of manufacturing report number 2015691-2025-07231.The event investigation, device evaluation, and applicable reporting activities will be performed under manufacturing report number 2015691-2025-07231.

• Brand Name: SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• 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: 22982464
• Report Number: 2015691-2025-07311
• Device Sequence Number: 15687885
• Product Code: NPT
• UDI-Device Identifier: 00690103215793
• UDI-Public: (01)00690103215793(17)260830(11)230831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 08/30/2026
• Device Model Number: 9755RSL20A
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 08/16/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: Required Intervention
• Patient Sex: Unknown