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

Model Number	9755RSL26A
Medical Device Problem Codes	Perivalvular Leak (1457); Malposition of Device (2616)
Health Effect - Clinical Code	Hemolytic Anemia (2279)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), 1 year, 3 months, and 7 days post-implant of a 26 mm sapien 3 ultra resilia (s3ur) valve in the aortic position, the 26 mm sapien 3 ultra resilia valve required intervention due to paravalvular leak (pvl) which was suspected to be caused by under expansion of the valve.It was also suspected that the valve was implanted slightly higher than the native annulus.A new 26mm s3ur was implanted at 80/20 in relation to the initial 26mm s3ur.The valve was deployed with nominal volume (23cc) and post dilated with a 26mm true balloon.The patient was in stable condition after the procedure.The patient developed anemia after their valve implant and was referred to hematology.The patient noted they have been tired.Recently their hemoglobin dropped even further with an elevated ldh, reticulocyte count, and a low haptoglobin, all consistent with hemolysis.The patient was hospitalized (b)(6) 2026 and had a transthoracic echocardiogram that was performed at the end of (b)(6) 2026, which showed moderate-to-severe paravalvular insufficiency.
Additional Manufacturer Narrative
H6 investigation findings: hematological problem identified.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential adverse event associated with the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to malposition, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, preserved ejection fraction, significant landing zone calcification, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.The ifu cautions that incorrect sizing of the valve may lead to paravalvular leak, migration, or embolization.The device training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valves (all models).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor in the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for malposition (i.E., minimal leaflet calcification, severe septal hypertrophy), balloon valvuloplasty may indicate potential balloon movement during valve deployment.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Due to a limited amount of information received, it is unknown what could have caused or contributed to this event of malposition.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.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.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the landing zone, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post-deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the landing zone, uneven distribution of calcium on the landing zone, bulky or severe calcification, an elliptical annulus shape, and valve under-sizing.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.Hemolysis is the destruction of red blood cells.There are multiple extrinsic and intrinsic factors including use of extracorporeal circulation, transfusion, infection, tumors, autoimmune disorders, medication side effects, a metabolic abnormality, and red blood cell membrane instability.Normal red blood cells (erythrocytes) have a lifespan of about 120 days.After the lifespan is over the red blood cells break down and are removed from the circulation by the spleen.In some medical conditions, or because of taking certain medications, this breakdown of red blood cells is increased.Medications that have been associated with hemolysis include acetaminophen, penicillin, and other pain medications.Red cells may be destroyed due to defects in the cells themselves.Another cause of hemolytic anemia is break down due to mechanical damage, such as from artificial heart valves or heart-lung bypass; or they as a result of turbulent blood flow pattern and erythrocyte destruction caused by pvl or central regurgitation.Edwards extensively trains physicians before they are qualified to use the sapien transcatheter heart valves (all models).The device training manuals instructs the operator on proper imaging screening requirements, including the use of good quality echocardiography and/or computed tomography (ct) to appropriately measure the landing zone, assess the content and distribution of calcium, and other patient anatomical factors.Multiple imaging modalities should be considered during valve size selection.Contraindications, important considerations when assessing the valve, and choosing the proper transcatheter heart valve are also discussed.The device training manuals also instruct the operator on proper positioning and deployment of the valve, including patients screening and procedural considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures are also included.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate the under expansion of the initial valve could have caused or contributed to the pvl with subsequent hemolysis/hemolytic anemia.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.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.

• 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: 25209514
• Report Number: 2015691-2026-15302
• Device Sequence Number: 13395980
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)270717(11)240717
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 9755RSL26A
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female