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

Model Number	9600TFX20A
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 1 year post tavr with a 20mm sapien 3 valve in the aortic position, a patient, who had a history of previous endocarditis underwent a post dilation due to stenosis, with pre-intervention mean/peak gradients between 20'35 mmhg.The most recent follow-up echocardiogram and progress notes were not available.The patient's symptomatic status prior to intervention is unknown, and it is anticipated that this information will be obtained.During the procedure, the physician performed balloon valvuloplasty on the previously implanted sapien valve.A second valve was not implanted.The most recent valve area/index and post-intervention gradient measurements are unknown.No follow-up echocardiographic data were available at the time of reporting.
Additional Manufacturer Narrative
Investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, h6: device codes, 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.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.The complaint for increased gradients was confirmed based on the information available to date.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of the ifu revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation 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.As reported, '1 year post tavr with a 20mm sapien 3 valve in the pulmonic position, a patient, who had a history of previous endocarditis underwent a post dilation due to stenosis, with pre-intervention mean/peak gradients between 20'35 mmhg.' elevated gradients may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to thrombosis or early valve degeneration.In this case, it was reported that, 'the patient symptomatic status prior to intervention (anticipated to be obtained) and was hospitalized with endocarditis'.Endocarditis is an infection of a native or prosthetic valve.Causes of prosthetic valve endocarditis are well documented in the literature and are typically classified as early (<60 days) or late (>60 days).In the bloodstream, endocarditis can multiply and spread across the inner lining of the heart (endocardium).The endocardium becomes inflamed, causing damage to heart valves/leaflets, resulting in obstruction of blood flow with increased gradients.It's also possible that the inflammation and/or damage of heart tissue caused by endocarditis can cause narrowing of the arteries and potentially valve stenosis with increased gradient.Additionally, bav was performed and, 'the mean gradient after intervention [was] 5mmhg.', which also indicated the implanted valve may initially under expanded.As such, available information suggests that patient factors (endocarditis) and/or procedural factors (under expanded valve) may have contributed to the complaint event; however, limited information was provided; therefore, a definitive root cause is unable to be determined at this time.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 the field clinical specialist (fcs), approximately 1 year post tavr with a 20mm sapien 3 valve in the pulmonic position, a patient, who had a history of previous endocarditis underwent a post dilation due to stenosis, with pre-intervention mean/peak gradients between 20'35 mmhg.The most recent follow-up echocardiogram and progress notes were not available.The patient's symptomatic status prior to intervention is unknown, and it is anticipated that this information will be obtained.During the procedure, the physician performed balloon valvuloplasty on the previously implanted sapien valve.A second valve was not implanted.The most recent valve area/index and post-intervention gradient measurements are unknown.No follow-up echocardiographic data were available at the time of reporting.Upon follow up, the fcs advised that the patient symptomatic status prior to intervention (anticipated to be obtained) and was hospitalized with endocarditis.Implant access and access site -ij and the mean gradient after intervention 5mmhg.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to administrative review, sections b5 corrected, g6, h2.Investigation is still ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information received, sections g6, h2, b5 updated.
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 1 year post tavr with a 20mm sapien 3 valve in the aortic position, a patient, who had a history of previous endocarditis underwent a post dilation due to stenosis, with pre-intervention mean/peak gradients between 20'35 mmhg.The most recent follow-up echocardiogram and progress notes were not available.The patient's symptomatic status prior to intervention is unknown, and it is anticipated that this information will be obtained.During the procedure, the physician performed balloon valvuloplasty on the previously implanted sapien valve.A second valve was not implanted.The most recent valve area/index and post-intervention gradient measurements are unknown.No follow-up echocardiographic data were available at the time of reporting.Upon follow up, the fcs advised that the patient symptomatic status prior to intervention (anticipated to be obtained) and was hospitalized with endocarditis.Implant access and access site -ij and the mean gradient after intervention 5mmhg.

• Brand Name: EDWARDS SAPIEN 3 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: 24109563
• Report Number: 2015691-2026-10487
• Device Sequence Number: 9713293
• Product Code: NPT
• UDI-Device Identifier: 00690103194005
• UDI-Public: (01)00690103194005(17)260416
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 02/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2026
• Device Model Number: 9600TFX20A
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/10/2026; 02/11/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/02/2026; 02/10/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• 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: 32 YR
• Patient Sex: Female