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

Model Number	11500A19
Medical Device Problem Codes	Degraded (1153); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional narrative surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as its availability is unknown.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 learned via implant patient registry that a 11500a 19mm aortic valve was explanted and replaced with a 11500a 23mm after an implant duration of 5 years, 9 months due to degeneration, pannus, stenosis, and regurgitation.The patient presented with hf and sob.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H11.Additional narrative: updated h6.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 most likely root cause is patient factors, including ckd.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.Pannus/host tissue overgrowth is most likely due to patient factors and is 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.A device history record (dhr) review was performed, and no relevant non-conformances were identified.

• 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: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21996212
• Report Number: 2015691-2025-03706
• Device Sequence Number: 4287785
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)200214
• 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: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2018
• 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: 61 YR
• Patient Sex: Female