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

Model Number	11500A19
Medical Device Problem Code	Thickening of Material (4056)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional 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.
Event or Problem Description
It was reported that a patient with a 19mm 11500a aortic valve was explanted after an implant duration of 2 years, 2 months due to leaflet thickening, restricted motion, and severe stenosis.The patient presented with heart failure symptoms.A 23mm 11500a valve was implanted in replacement.The patient was sent to recovery post-procedure.Per medical records, the patient presented with progressive shortness of breath secondary to decompensated heart failure with preserved ejection fraction (hfpef).The patient is to follow up for tavr evaluation and for further management.
Additional Manufacturer Narrative
H11.Additional narrative updated h6 leaflet thickening may be attributed to structural valve deterioration (svd), non-structural valve dysfunction (nsvd), thrombosis, endocarditis, or any combination of these factors.Leaflet thickened is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.There is insufficient information available regarding patient or procedural factors known to cause or contribute to leaflet thickening.Therefore, a definitive root cause cannot be conclusively determined.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were 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.

• 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; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24804320
• Report Number: 2015691-2026-13923
• Device Sequence Number: 10682713
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)240723
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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 Expiration Date: 07/23/2024
• Device Model Number: 11500A19
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female