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

Model Number	9755RSL23A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported to the implant patient registry (ipr), 1 year, 3 months, and 12 days post-implant of a 23 mm sapien 3 ultra resilia valve in the aortic position, the 23 mm sapien 3 ultra valve required intervention due to calcification and a valve in valve procedure (viv) was completed successfully.According to the medical records, an echo was performed that showed ejection fraction (ef) 60-65%, severe aortic stenosis, aortic valve area velocity time integral (ava vti) 0.74cm^2, mean gradient of 38.5mmhg, no regurgitation, and the leaflets were severely calcified.The patient was admitted for the viv.The valve was successfully deployed under rapid pacing, using single inflation and no apparent complications.The post viv echo showed a well-seated 26mm sapien 3 in the aortic position, with a mean gradient of 3mmhg, and trivial perivalvular leak.The patient was discharged home on post op day 1.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for completion of the investigation.The following sections have been added: b4, g3, g6, h2, h6, h11.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).In this case, the complaint for calcification was confirmed based on medical record.Available information suggests that patient factors (pre-existing comorbidities) likely contributed to the event as the patient had vast comorbidities (i.E.Htn, dm, hld, cardiovascular disease, cad, etc.).The process of calcification involves the reaction of calcium-containing extracellular fluid with membrane-associated phosphorus, causing calcification of the cells.Many patient-related factors can contribute to the onset and propagation of calcification, and consequently, structural degeneration of the thv.These factors include age, disease state, patient co-morbidities, and/or pharmacological intervention, such as but not limited to renal failure, hemodialysis, hypercholesterolemia, hyperlipidemia, hypothyroidism, diabetes mellitus, etc.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA 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: 24830939
• Report Number: 2015691-2026-14018
• Device Sequence Number: 16007511
• Product Code: NPT
• UDI-Device Identifier: 00690103215809
• UDI-Public: (01)00690103215809(17)260910(11)230911
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 09/10/2026
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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: 80 YR
• Patient Sex: Male