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

Model Number	9750TFX23A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/11/2026
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 remained implanted and was not returned to edwards lifesciences 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 has historically been due to patient factors (age, disease state, patient co-morbidities, and/or pharmacological intervention).The valve calcification and need for valve reintervention were confirmed.Available information suggests that patient factors (end stage renal disease) likely contributed to the event as the patient had end-stage renal disease due to iga nephropathy on dialysis.These factors may include patient age, underlying disease state, patient comorbidities (e.G., renal failure, including hemodialysis, hypercholesterolemia, hyperlipidemia, hypothyroidism, diabetes mellitus, antiphospholipid antibody syndrome), and concomitant pharmacological interventions.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 an edwards lifesciences field clinical specialist, approximately (b)(6) post implant of a 23mm sapien 3 ultra valve in the aortic position, the patient was being evaluated for a thv-in-thv procedure.Per proctor review, the patient is presenting with structural valve deterioration, manifesting as central aortic regurgitation.The prosthetic leaflets demonstrate calcification and early fibrotic changes.Per additional information received, the patient passed away after approximately (b)(6) post implant.Per the medical record, the patient was admitted with colitis and gi symptoms of abdominal pain, vomiting & diarrhea and developed refractory hypotension requiring vasopressor support, consistent with sepsis.During this hospitalization, an echo demonstrated chronically elevated gradients across the previously implanted tavr aortic valve with moderate central regurgitation; however, left ventricular systolic function remained preserved, no valvular thrombus or vegetations were identified, and cardiology assessed that the elevated gradients were exacerbated by a high output state related to sepsis, anemia, and arteriovenous dialysis access rather than acute device malfunction.The patient also had severe pulmonary hypertension with moderate to severe tricuspid regurgitation, end stage renal disease on dialysis, antiphospholipid antibody syndrome, and chronic cardiovascular disease, all of which significantly limited physiologic reserve.At baseline, patient stated that they would get short of breath with more than normal activity at home.Despite the patient passing away prior to undergoing valve reintervention, a valve in valve procedure was being actively considered per the medical record, including formal work up and proctor review.There is insufficient evidence to conclude that the transcatheter aortic valve directly caused or contributed to the patient's death, which is most appropriately attributed to complications of sepsis and underlying advanced disease rather than device failure.

• 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: 25178364
• Report Number: 2015691-2026-15198
• Device Sequence Number: 18830195
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)230113
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 01/13/2023
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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: 63 YR
• Patient Sex: Female