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

Model Number	9755RSL23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Septic Shock (2068)
Date of Event	04/17/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, approximately 11 months post tavr the patient passed away.There is no death/discharge summary or cause of death available in patient's chart review.After reviewing the medical records provided, the patient is a 63-year-old female with significant comorbidities including end-stage renal disease on hemodialysis, severe prosthetic aortic stenosis status post transcatheter aortic valve replacement, congestive heart failure, type 2 diabetes mellitus, paroxysmal atrial fibrillation not anticoagulated due to prior gastrointestinal bleeding, and chronic gastrointestinal pathology with colostomy, who underwent implantation of a 23 mm sapien 3 ultra resilia valve in the aortic position on (b)(6) 2025.The patient was admitted on (b)(6) 2026 for hypotension and altered mental status following dialysis and was found to be in septic shock with lactic acidosis requiring vasopressor support and intensive care unit management.Infectious evaluation demonstrated leukocytosis, elevated lactate, positive respiratory syncytial virus polymerase chain reaction, left lower lobe infiltrate, and methicillin-resistant staphylococcus aureus polymerase chain reaction positivity, consistent with viral pneumonia with possible superimposed bacterial infection.Broad-spectrum antibiotics were administered and blood cultures remained negative.Initial clinical improvement was observed with resolution of encephalopathy, decreasing lactate levels, and return to baseline mental status.The hospital course was complicated by acute on chronic thrombocytopenia with a nadir of 45,000/'l and development of digital ischemia involving the right toes and left hand, concerning for vasculopathy or atheroembolic phenomena, as well as worsening anemia requiring packed red blood cell transfusion.Transthoracic echocardiography confirmed severe prosthetic aortic stenosis and moderate to severe tricuspid regurgitation, while transesophageal echocardiography was deferred due to thrombocytopenia.Anticoagulation remained withheld due to bleeding risk.On (b)(6) 2026, the patient developed profound hypoglycemia with associated hypotension while nothing by mouth for a planned transesophageal echocardiography, requiring glucose administration and escalation of vasopressor support.Subsequently, supraventricular tachycardia with rapid ventricular response occurred and was managed with adenosine and amiodarone infusion.Progressive respiratory failure necessitated endotracheal intubation, and continuous renal replacement therapy was initiated due to hemodynamic instability and intolerance to intermittent hemodialysis.Despite maximal supportive care, the patient experienced persistent refractory shock, acute hypoxic respiratory failure, worsening renal and hepatic dysfunction, ongoing lactic acidosis, refractory arrhythmias, and progressive digital ischemia.Due to continued clinical decline, a transition to comfort care was elected by the family.The patient expired on (b)(6) 2026, with causes of death including shock, acute respiratory failure, end-stage renal disease, and severe aortic stenosis.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to 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, 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 medical records.As reported, 'the patient expired on 04/17/2026, with causes of death including shock, acute respiratory failure, end-stage renal disease, and severe aortic stenosis.' available information suggests that patient factors (esrd-hemodialysis) likely contributed to the event as the patient had vast pre-existing comorbidities, especially, esrd with hemodialysis.Patients undergoing hemodialysis and renal replacement therapy have been found to develop calcification at earlier ages.Additionally, patients with mitral annulus calcification are on average older than those without calcification; however, mitral annulus calcification has been detected with increased frequency at younger ages in patients with uremia.The duration of dialysis also plays a major role in the development of calcification.The presence of coronary artery calcification in the dialysis population can result in increased gradient or stenosis.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 RESILIA 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: 25162298
• Report Number: 2015691-2026-15152
• Device Sequence Number: 8660571
• Product Code: NPT
• UDI-Device Identifier: 00690103215809
• UDI-Public: (01)00690103215809(17)271126(11)241126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/03/2026

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: 9755RSL23A
• 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: 04/19/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• 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: 63 YR
• Patient Sex: Female