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

Model Number	9750TFX20A
Medical Device Problem Codes	Degraded (1153); Gradient Increase (1270); Difficult to Open or Close (2921); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event(s) reported is/are anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode(s) 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.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.In this case, the complaints of increased gradients, central regurgitation, leaflet motion restricted and leaflet thickened have been confirmed based on the information available to date.Any updates or additional findings will be submitted in accordance with fda reporting requirements.The patient had vast comorbidities (e.G.Hypertension, hypothyroidism, diabetes, hyperlipidemia, morbid obesity, etc.), which are known factors that may increase the risk of atherosclerosis leading to early valve degeneration/stenosis with thickened leaflet, resulting in leaflet motion restriction and central regurgitation.In addition, thickened leaflets could narrow the opening and obstruct the blood flow across the valve, leading to increased gradients.As such, available information suggests that patient factors (pre-existing comorbidities) may have contributed to the complaint event; however, a definitive root cause is unable to be determined.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 the field clinical specialist, approximately 4 years and 6 months post transfemoral tavr (transcatheter aortic valve replacement) procedure with a 20mm sapien 3 ultra (s3u) valve in the native aortic position, the patient presented with recurrent heart failure admissions, dyspnea on exertion, and fatigue.The s3u valve showed mild aortic insufficiency, severe prosthetic aortic stenosis, a mean gradient of 36 to 42mmhg, and restriction of mobility with thickness of the leaflets.As treatment, the patient was put on eliquis for 3 months, but per report, the valve is still deficient.The physician requested a proctor review.The patient underwent a successful valve-in-valve procedure with a 20mm sapien 3 ultra resilia valve.

• Brand Name: EDWARDS SAPIEN 3 ULTRA 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: 22810633
• Report Number: 2015691-2025-06659
• Device Sequence Number: 18380342
• Product Code: NPT
• UDI-Device Identifier: 00690103201314
• UDI-Public: (01)00690103201314(17)220729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/14/2025

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: 07/29/2022
• Device Model Number: 9750TFX20A
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2020
• 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: 76 YR
• Patient Sex: Female