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

Model Number	9750TFX23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event reported is 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.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the instructions for use (ifu), training manuals and current risk mitigations 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, stenosis/increased gradient events for the s3, s3u, s3ur valves post-implantation have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to patient factors (atherosclerosis, thrombosis, endocarditis, rheumatic fever, pannus formation) and/or procedural factors (under-deployed valve, valve size selection, patient-prosthesis mismatch).The complaint for stenosis was confirmed based on available information to date.As reported, "a tte performed approximately 4 years and 7 months post tavr revealed ef 55-60%, mg 29mmhg, ava 0.7." available information suggests that patient factors (pre-existing comorbidities) likely contributed to the event as the patient had vast comorbidities (i.E.Htn, hld, dm2, etc.), which are known factors that may increase risk for early valve degeneration, resulting in stenosis.Especially, hyperlipidemia could be a risk factor for calcification as there are pathophysiological similarities between calcification and atherosclerosis.Several studies have documented a correlation between lipids and calcification and found that both coronary calcification and aortic valve calcification progress more rapidly in subjects with low-density lipoprotein (ldl) levels.Ldl levels have been found to have a stronger correlation with coronary calcification than age, sex, blood pressure, fasting, insulin level, or smoking, which can result in increased gradient or valve stenosis.In addition, diabetes mellitus (dm) could also be a risk factor for bioprosthetic heart valve calcification, which can lead to valve stenosis.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.
Event or Problem Description
As reported by a field clinical specialist, a patient underwent a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 23mm sapien 3 ultra valve in aortic position.Approximately 4 years and 10 months later, the patient was being workup for a failed valve.As per follow-up with the vcc, a tte performed approximately 4 years and 7 months post tavr revealed ef 55-60%, mg 29mmhg, ava 0.7, di 0.2, peak velocity 3.51m/s, la severely dilated, mild mitral regurgitation.Two weeks later an additional tte was performed which revealed ef 50-55%, mg 30mmhg, peak velocity 2.5m/s, and la moderately dilated.The patient then underwent a valve in valve approximately 4 years and 10 moths post tavr with a non-edwards valve inside the pre-existing 23mm sapien 3 ultra valve in aortic position.

• Brand Name: US SAPIEN 3 ULTRA 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: 25143045
• Report Number: 2015691-2026-15077
• Device Sequence Number: 9454031
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)221019
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 10/19/2022
• Device Model Number: 9750TFX23A
• 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: 02/19/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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: 83 YR
• Patient Sex: Female