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

Model Number	9755RSL20A
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.Per the instructions for use (ifu), nonstructural dysfunction is a potential adverse event associated with the use of the valve.Growth of abnormal tissue around a prosthetic heart valve, termed as pannus formation, is one of the important causes for nonstructural prosthetic valve dysfunction that may require intervention.Pannus may interfere with the functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Protrusion of the pannus into the valve orifice area may disturb blood flow through the valve and finally result in prosthetic valve stenosis.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results indicate the cause of the event is unknown due to the limited information available.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.
Event or Problem Description
As reported by implant patient registry, approximately 1 year and 9 months post transfemoral tavr procedure with a 20 mm sapien 3 ultra resilia valve, the valve was explanted and a surgical valve was implanted.The cause of the explant is due to calcification and aortic valve pannus.According to the medical records, a pre-procedure tee was provided that showed aortic valve with tavr in previously placed surgical aortic valve replacement (savr) which appeared well-seated, mean gradient of 41mmhg, calcification seen on the prosthetic leaflet of where the native right coronary cusp (rcc) would be, no paravalvular leak (pvl) or aortic insufficiency.The patient went for a tavr explant of their sapien 3 ultra resilia on which was replaced with a 23 mm non-ew mechanical valve.Other procedures performed at this time include redo sternotomy, aortic/lvot patch root enlargement, pulmonic root re-replacement: 25 mm tissue conduit, and a left coronary 6mm dacron graft.Post-op tee showed the av was replaced by a 23mm non-ew mechanical valve and findings were consistent with a normal functioning prosthetic valve.The explanted tavr valve was found to have aortic valve pannus.The tavr explant was sent for pathology and showed a portion of cardiac valvular tissue with calcifications.There were no procedural complications.

• Brand Name: EDWARDS 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: 25295979
• Report Number: 2015691-2026-15536
• Device Sequence Number: 21160894
• Product Code: NPT
• UDI-Device Identifier: 00690103215793
• UDI-Public: (01)00690103215793(17)260726(11)230727
• 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: 2024
• Device Explanted Year: 2026
• 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): 07/01/2026

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 Expiration Date: 07/26/2026
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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 Age: 20 YR
• Patient Sex: Female