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

Model Number	11500A21
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: device evaluation anticipated, but not yet begun.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
Edwards received notification from greece that this inspiris resilia valve model (b)(6) , implanted in aortic position, was explanted after an implant duration of 2 years and 1 month due to a sub-valvular thrombosis.The patient presented with mild shortness of breath prior to the intervention.Another bioprosthetic valve was implanted in replacement.As reported, the patient did not suffer any further injury due to this event.
Event or Problem Description
Edwards received notification from greece that this inspiris resilia valve model 11500a21, implanted in aortic position, was explanted after an implant duration of 2 years and 1 month due to a sub-valvular thrombosis.The thrombosis was diagnosed, and confirmed on the pre-operative echocardiography, after 2 years post-implantation of the subject device.Per product evaluation findings, moderate host tissue overgrowth was also observed.The patient presented with mild shortness of breath prior to the intervention and was not on anticoagulant medication at the time the thrombosis was diagnosed.Another bioprosthetic valve was implanted in replacement.The patient did not suffer any further injury due to this event and was noted as to be discharged in very good condition after the procedure.
Additional Manufacturer Narrative
Information added/updated to section b5.Corrected data in section g1.H3: device evaluation: the device was returned for evaluation.Customer report of thrombosis was confirmed through visual observations.As received, x-ray demonstrated commissure 1 was bent inwards and band was pushed outwards around commisure1; the vfit cocr alloy band was not expanded.Minimal fibrin-like material was observed on all leaflets on the inflow and outflow aspects.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 5mm on leaflet 2 on the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 3 on the outflow aspect.Host tissue on the stent circumference was moderate at the inflow aspect and minimal at the outflow aspect.Wireform was exposed on commissures 1 and 2 and metal band was exposed around leaflet 2 on the inflow aspect.Sewing ring cloth had multiple cuts around the valve and exposed silicone of sewing ring.H11: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Additional Manufacturer Narrative
Information added/updated to section d4 (udi) and h6 (type of investigation, investigation findings and investigations conclusions).Additional h6 (type of investigation) code: labelling review.H11: additional manufacturer narrative: the instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A device history record (dhr) review was performed, and no related manufacturing nonconformances were identified.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 (bpvt) is one category of bioprosthetic valve dysfunction and is an increasingly recognized complication of tissue valve prosthesis.Bpvt usually occurs late after implantation and can be further categorized into two subcategories: clinical valve thrombosis (cvt) and subclinical valve thrombosis (slt).Clinical valve thrombosis is defined as clinically apparent prosthetic valve dysfunction with the typical finding of an increased transvalvular gradient with a mobile mass/thrombus on the prosthetic heart valve as visualized by echocardiography or multi-detector computed tomography (mdct).Pannus is a non-immune inflammatory reaction of the body to the implanted prosthesis, characterized by proliferation of fibroelastic tissue and collagen, with a starting point in the suture area and subacute or chronic centripetal evolution.Pannus can have both beneficial and harmful effects depending on the amount of growth and location.A small amount of host tissue growth over the suture line is expected and is needed to form a non-thrombogenic surface and complete the healing process after device implantation.In contrast, an excessive amount of pannus growth can cause nonstructural dysfunction that may require intervention.Host tissue growth can extend onto the cusp surfaces leading to thickening of the cusps, cusp retraction or curling, leaflet immobility, and/or abnormal coaptation, potentially resulting in valvular regurgitation, elevated gradients, and/or stenosis.Thrombosis and pannus/host tissue overgrowth are most likely due to patient factors and are unlikely to be related to a manufacturing non-conformance.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.The most likely root cause is patient factors.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 23903381
• Report Number: 2015691-2025-10609
• Device Sequence Number: 5092649
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)270611(11)230612
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 11500A21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 02/25/2026
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 02/05/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 90 KG