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

Model Number	11500A
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available for evaluation, as it remains implanted in the patient.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
It was reported that a patient with a 25mm 11500a aortic valve after an implant duration of 9 months and 24 days underwent percutaneous repair due to pvl.The patient received an amplatzer plug to repair pvl.Per medical records, due to complexity patient anatomy and significant pvl, repair was recommended than viv tavr or repeat surgery.The patient underwent pvl repair using amplatzer vsd occluder device.Echo on pod#1 showed a bioprosthetic aortic valve is present and appears well seated.
Additional Manufacturer Narrative
Updated sections: g3, g6, h6 type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Paravalvular/perivalvular leak (pvl) refers to blood flowing through a channel between the sewing ring of the implanted valve and the cardiac tissue due to an insufficient seal of the valve to the annulus.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl, as the bioprosthesis may not seat properly after debridement.Technique related factors during implantation, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may also create difficulty seating the bioprosthetic valve, resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.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 pvl.Therefore, a definitive root cause cannot be conclusively determined.

• 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; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24477053
• Report Number: 2015691-2026-11641
• Device Sequence Number: 21409618
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)290801(11)240802
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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: 79 YR
• Patient Sex: Male