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

Model Number	9750TFX26A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is onging.
Event or Problem Description
As reported by implant patient registry, approximately 3 years and 5 months post transfemoral tavr procedure with a 26mm sapien 3 ultra valve in the aortic position the valve was explanted due to unknown reasons.After reviewing the medical records provided, the patient is a 67-year-old female, with a past medical history significant for aortic stenosis, heart failure with preserved ejection fraction, pulmonary hypertension, hypertension, type ii diabetes mellitus, autoimmune liver disease, esophageal varices, and tobacco abuse, who underwent implantation of a 23 mm sapien 3 ultra valve in the aortic position on (b)(6) 2022.Approximately 3 years and 4 months post-implantation, the patient presented to the emergency department on (b)(6) 2026, with syncope and loss of consciousness.Due to valve degeneration, the 23 mm sapien 3 ultra valve was explanted on (b)(6) 2026.Echocardiographic evaluations demonstrated severe bioprosthetic aortic stenosis with diffuse leaflet thickening and moderate leaflet calcifications, consistent with leaflet thrombosis/hypo-attenuated leaflet thickening and ava of 0.7cm2.Pathologic examination of the explanted valve described three tan-brown, rubbery, indurated cusps with focal thickening and diffuse calcification.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to medical record review and engineering evaluation findings, sections g6, h2, type of investigation, investigation findings, investigation conclusions and h11 has been added.The event(s) reported is/are 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(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.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, structural valve degeneration related to calcification for the sapienxt, 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 factors (age, disease state, patient co-morbidities, and/or pharmacological intervention).The complaint for calcification was confirmed based on medical record.As reported, 'echocardiographic evaluations demonstrated severe bioprosthetic aortic stenosis with diffuse leaflet thickening and moderate leaflet calcifications, consistent with leaflet thrombosis/hypo-attenuated leaflet thickening and ava of 0.7cm2.' available information suggests that patient factors (pre-existing comorbidities) likely contributed to the event as the patient had vast comorbidities (i.E.Htn, dm ii, etc.).These factors may include patient age, underlying disease state, patient comorbidities (e.G., renal failure, including hemodialysis, hypercholesterolemia, hyperlipidemia, hypothyroidism, diabetes mellitus), and concomitant pharmacological interventions.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24957667
• Report Number: 2015691-2026-14595
• Device Sequence Number: 20185016
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250126
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/04/2026

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: 01/26/2025
• Device Model Number: 9750TFX26A
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2022
• 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: 67 YR
• Patient Sex: Female