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

Model Number	9750TFX20A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the instructions for use (ifu), non-emergent reoperation, emergency cardiac surgery, reoperation, device migration or malposition requiring intervention and device explant are listed as potential risks associated with the device and transcatheter valve replacement (tvr) procedure.The ifu cautions that long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism.Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician.This device has not been tested for use without anticoagulation.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.Valve reintervention may be due to valve dysfunction (e.G., severe, or clinically significant paravalvular leak, central leak, significant malposition, early/late endocarditis, thrombosis, structural valve deterioration or degeneration) and/or other reasons unrelated to the edwards devices (e.G., treatment of other patient comorbidities).During the manufacturing process, all sapien valves (all models) are 100% visually inspected for defects and 100% tested under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.In this case, despite multiple investigational attempts, it was not possible to obtain additional details regarding this event.Due to limited information, a definitive root cause was unable to be determined at this time.At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device or that the use or miss-use of the device caused or contributed to the event.There is no allegation of deficiencies related to the identity, quality, durability, reliability, safety, labeling effectiveness, or performance of this edward device.Should additional information become available, the information will be reviewed, and the file updated accordingly.The ifu and training manuals have been reviewed, and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.
Event or Problem Description
As reported by implant patient registry, approximately 3 years post transfemoral tavr procedure with a 20 mm sapien 3 ultra valve, the valve was explanted, and a surgical valve was implanted.The cause of the explant is unknown.
Additional Manufacturer Narrative
A supplemental report is being submitted due to the medical records received.An addition was made to b.1 and b.5.A correction was made to b.7, h.6: clinical code, device code, investigation findings, investigation conclusion, and h.11.An update was made to b.4, g.6.Investigation is ongoing.
Event or Problem Description
As reported by implant patient registry, approximately 3 years post transfemoral tavr procedure with a 20 mm sapien 3 ultra (s3u) valve, the valve was explanted, and a surgical valve was implanted.Per medical record review, the patient s/p transfemoral tavr with a 20 mm s3u aortic valve presented with severe exertional dyspnea and was diagnosed with severe prosthetic aortic valve stenosis.The early onset of stenosis was attributed, at least in part, to the small valve size, and root enlargement or replacement was needed.The patient underwent an aortic valve replacement, root enlargement, coronary artery bypass grafting, and a maze procedure with left atrial appendage clip placement.Preoperative diagnoses included stenotic tavr, permanent atrial fibrillation, active tobacco use (unwilling to cease), obesity, and a severely calcified aorta with 50% stenosis of the left anterior descending artery.Intraoperatively, the s3u valve was removed intact from the aortic root without damage to the native aorta.A 23 mm inspiris resilia valve was implanted following annular enlargement from 20 mm to 23 mm.The surgeon noted a severely stenotic tavr and a severely calcified aorta.The surgical pathology report described the explanted valve as a cylindrical, silver metallic valve measuring 1.5 to 2.0 cm in diameter and 1.6 cm in length, with minimal pink-tan soft tissue grossly present.The patient's presentation was consistent with prosthetic valve stenosis.
Additional Manufacturer Narrative
A supplemental report is being submitted for the completed engineering evaluation.Sections b.4, g.3, g.6, and h.2 have been updated.Corrections have been made to h.6: type of investigation, investigation findings and investigation conclusion.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 edwards 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 sapien 3, sapien 3 ultra, sapien 3 ultra resilia 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 the medical records provided.It is possible that one or more patient/procedural factors identified in the technical summary may have been present and contributed to the complaint event.However, due to insufficient information, a definitive root cause is unable to 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 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: 22874701
• Report Number: 2015691-2025-06918
• Device Sequence Number: 12206418
• Product Code: NPT
• UDI-Device Identifier: 00690103201314
• UDI-Public: (01)00690103201314(17)250322
• 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: 2022
• Device Explanted 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,Followup
• Report Date (Section B): 10/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2025
• Device Model Number: 9750TFX20A
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/19/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/15/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2022
• 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: 65 YR
• Patient Sex: Female