MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 20MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9755RSL20A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the edwards field clinical specialist, a 20m sapien 3 ultra resilia valve was successfully implanted into a non-edwards 26mm thv no procedural complications.A unicorn procedure involving the left leaflet was performed, and mild central aortic insufficiency (ai) was noted.The patient was alive at procedure completion.Given the high implant height of the prior valve and elevated risks for sinus sequestration, coronary obstruction, and surgical complications related to kidney disease, the case was deemed high risk.Ecmo was initiated preemptively and later successfully discontinued.The patient is currently clinically stable, with improved ai despite persistent leaflet interaction.Approximately nine days later, the patient returned to the cath lab, where catheter-based removal of a flail leaflet from the prior non-edwards valve was performed, resolving the central ai.The patient had an edwards surgical valve implanted approximately 7 years prior, followed by a non-edwards thv approximately 5 years later.The non-edwards valve developed a flail leaflet causing severe ai, which subsequently interfered with one leaflet of the newly implanted sapien 3 ultra resilia valve, resulting in mild-to-moderate central regurgitation.
Additional Manufacturer Narrative
The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery was provided and reviewed, but it was insufficient to evaluate the reported central regurgitation and possible flail leaflet of the pre-existing valve.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Through extensive complaint investigations, central regurgitation events post-deployment with or without report related to leaflet mobility for the s3, s3u, and s3ur valves have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to patient and/or procedural factors (malposition, slow recovery of blood flow, leaflet impingement due to calcification or guidewire, over-inflation, post-dilation, and/or under-expansion).A unicorn procedure was performed, which may have contributed to the reported flailed leaflet of the pre-existing non-edwards thv.There is no indication that the s3ur valve was malposition in this case; however, the resulting interference where the flailed leaflet impacts thv leaflet coaptation resembles the mechanism seen in native leaflet overhang associated with malposition thvs, a condition known to cause central regurgitation.Leaflets hanging over and covering the outflow of the valve can interfere with proper leaflet coaptation, resulting in central regurgitation as reported.The complaint for valve exhibits central regurgitation post valve deployment was confirmed based on the information available to date.In this case, available information suggests procedural factors (overhanging / flailed leaflet) likely contributed to the event based on the reported information.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, 20MM
• 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 vandorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24552518
• Report Number: 2015691-2026-13059
• Device Sequence Number: 9485517
• Product Code: NPT
• UDI-Device Identifier: 00690103215793
• UDI-Public: (01)00690103215793(17)280227(11)250227
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 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: 02/12/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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