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

Model Number	11500A
Medical Device Problem Codes	Calcified (1077); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis in this case was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation as it remains implanted in the patient.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 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 and learned through investigation that a patient with a 19mm 11500a aortic valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 6 years, 2 months due to stenosis.The patient presented with sob.
Additional Manufacturer Narrative
H11: additional manufacturer narrative:.
Event or Problem Description
It was learned through implant patient registry that a 19mm 11500a resilia aortic valve in aortic position was explanted and replaced with a 23mm 11060a konect valved conduit after an implant duration of 6 years, 6 months due to stenosis.The patient presented with sob.Reportedly, patient was in recovery post-procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, b5, g3, g6, h2, h6 (investigation findings, and investigation conclusions).Engineering evaluation summary: calcification: per (b)(4), svd is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv implantation.The common endpoint of all these factors is calcification and degradation.Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the root cause remains indeterminable as no patient or procedural factors known to cause or contribute to svd were reported.Ppm: per (b)(4), patient prosthesis mismatch (ppm) is present when the effective orifice area of the implanted bioprosthetic valve is too small in relation to body size.Literature indicates ppm main hemodynamic consequence is to generate higher than expected gradients through a normally functioning bioprosthetic valve.It has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.Improperly sized valves with ppm can hasten the development of early degenerative changes and premature prosthetic valve dysfunction with varying degrees of prosthetic valve stenosis and regurgitation.Although ppm is a well-recognized phenomenon of bioprosthetic valves, it is most likely related to patient anatomical changes after long implant durations.When discovered intraoperatively or early post-operatively, ppm is most likely related to procedural factors, including specific patient assessment and valve model and size selection.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.The most likely root cause is patient factors, including patient anatomy and the reported patient condition htn.
Event or Problem Description
It was learned through implant patient registry and investigation that a 19mm 11500a resilia aortic valve in aortic position was explanted and replaced with a 23mm 11060a konect valved conduit after an implant duration of 6 years, 6 months due to calcific degeneration with stenosis, and prosthesis patient mismatch.The patient presented with dyspnea.Reportedly, patient was in recovery post-procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h6 (type of investigation, investigation findings, and investigation conclusions).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 reported 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; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21646117
• Report Number: 2015691-2025-02059
• Device Sequence Number: 7922286
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)190922
• 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: 2018
• Device Explanted 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,Followup,Followup
• Report Date (Section B): 09/12/2025

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: 09/22/2019
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/29/2025; 09/05/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 07/23/2025; 08/22/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2017
• 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; Other; Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female