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

Model Number	9755RSL20A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Chest Pain (1776); Pseudoaneurysm (2605)
Date of Event	06/11/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, a patient with a 20mm s3ur aortic valve implanted for 1 year and 9 months expired during a surgical procedure to do a hemi arch and possible explant of the 20mm s3ur valve.Per medical records, the patient sought treatment at the ed for chest pain and was admitted for aneurysm aortic without rupture, numerous pseudoaneurysm, and prosthetic aortic valve stenosis.A cardiac ct during this admission revealed multilobulated aneurysm involving the aortic arch and descending aorta.Compared to a prior ct, there was no significant change in size or appearance of the pseudoaneurysm at the aortic root or change in the size or appearance of multiple additional pseudoaneurysms of the distal ascending aorta and aortic arch.There was a focal outpouching (14 x 16 x 9 mm), located below the right sinus of valsalva communicating with the lvot (mycotic pseudoaneurysm versus postsurgical).There was surgical material in the adjacent membranous interventricular septum with mildly thickened leaflets.The patient underwent a procedure for bentall root replacement, aortic annulus enlargement, reconstruction of the lvot, interposition svg to lm and rca, cabg x 2, repair of multiple aneurysms ascending aorta, hemiarch replacement, and placement of iabp.There were complications intraoperatively with post bypass vf requiring cpr, iabp placement and requiring vasopressin drugs.There was no lv function and minimal rv function.The heart did not recover.Attempts to wean off bypass were unsuccessful and the patient passed away.
Additional Manufacturer Narrative
Updated section h6- type of investigation, findings, and conclusions.The device was not returned for evaluation as it remained implanted.The complaint for leaflet thickened/halt was confirmed based on the provided medical records.A review of the dhr, lot history and complaint 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 ultra resilia 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.Hypoattenuated leaflet thickening (halt) may be caused by several patient-related factors including early valve deterioration (svd) (e.G.Stenosis/calcification), non-structural dysfunction (e.G.Pannus), or thrombosis (formation of blood clots on the valve).In this case, limited information was provided; therefore, a definitive root cause is unable to be determined at this time.Per the instructions for use (ifu), cardiovascular injury including hematoma, perforation or dissection of vessels, ventricle, atrium, septum, myocardium or valvular structures that may require intervention are known potential adverse events associated the overall transcatheter valve replacement (tvr) procedure and may require intervention.A pseudoaneurysm is a leakage of arterial blood from an artery into the surrounding tissue with a persistent communication between the originating artery and the resultant adjacent cavity.This may occur after arterial puncture for a diagnostic cardiac catheterization or an arteriogram but is more common after an arterial intervention.Catheter-directed interventions more commonly require larger arterial sheaths to be used, and the anticoagulation or antiplatelet agents that are administered can interfere with normal sealing of the puncture site.Some pseudoaneurysms resolve themselves, though others require treatment to prevent hemorrhage, an uncontrolled leak, or other complications.Surgery is sometimes required.Edwards extensively trains physicians before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate patient factors such as marfan syndrome and endocarditis may have caused or contributed to this event.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 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 Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 22523254
• Report Number: 2015691-2025-05795
• Device Sequence Number: 7951022
• Product Code: NPT
• UDI-Device Identifier: 00690103215793
• UDI-Public: (01)00690103215793(17)260122(11)230123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2026
• Device Model Number: 9755RSL20A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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: Death; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male