MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	11500A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported and learned through the investigation that a patient with a 21mm 11500a aortic valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of (b)(6) due to central regurgitation and leaflet thickened (halt).Based on the ct review, this appears to be an early valve dysfunction.The leaflets look clearly hypoattenuated and thickened, raising suspicion for leaflet pathology - halt - that may not be purely structural degeneration.This patient plan of care is anticoagulation for approximately 3 months for possible halt and have either a repeat echo or cta.It was learned patient successfully underwent tavr with a 20mm 9755rsl transcatheter valve.The patient was recovering in stable condition post-procedure.
Additional Manufacturer Narrative
Thrombosis is a condition in which blood coagulates and creates what is commonly known as blood clots.Thrombosis can cause life-threatening conditions requiring immediate medical attention.Bioprosthetic valve thrombosis is one category of bioprosthetic valve dysfunction and is an increasingly recognized complication of tissue valve prosthesis.Bioprosthetic valve thrombosis usually occurs late after implantation and can be further categorized into two subcategories: clinical valve thrombosis and subclinical valve thrombosis, subclinical leaflet thrombosis is described as a thin layer of thrombus that can involve one or all three leaflets, with typical appearance on mdct as a hypo-attenuating defect of the leaflets, also called hypo-attenuating leaflet thickening.Based on the information available, the most likely cause is patient factors.The subject device is not available for evaluation as it remains implanted in the patient.The instructions for use (ifu) 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.The reported type of event is included in the ifu.The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 25249968
• Report Number: 2015691-2026-15441
• Device Sequence Number: 10501087
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)280115(11)240116
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 11500A
• 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: 05/14/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female