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

Model Number	9750TFX23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/13/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs) the patient had a transfemoral transcatheter aortic valve replacement (tavr) with a 23mm sapein 3 ultra resilia valve and approximately 6 months and 27 days later the patient expired.The patient was admitted on 2 days prior to passing with acute on chronic heart failure with preserved ejection fraction complicated by acute respiratory failure and pleural effusions.The transthoracic echocardiogram (tte) performed one day before the patient expired showed severe prosthetic valve aortic stenosis, with an aortic valve mean gradient of 85mmhg and aortic valve area vti of 0.31 cm2.After discussions involving family and the patient's power of attorney (poa), code status was clarified as do not resuscitate/do not intubate.The patient was transitioned to comfort-focused care and ultimately patient expired.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and conclusions in this section have been updated.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 provided medical record.It is possible that patient or procedural factors identified in the technical summary contributed to the complaint event.However, due to insufficient information, a definitive root cause cannot be determined.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS LIFESCIENCES SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards lifesciences; 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: 25092477
• Report Number: 2015691-2026-14946
• Device Sequence Number: 10018428
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)280424
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/26/2026

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: 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Female