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

Model Number	11500A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a 19mm 11500a aortic valve in aortic position was explanted and replaced with a 21mm 11060a konect valved conduit after an implant duration of 1 year, 2 months and 14 days.The reason for reintervention was not provided.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 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.
Event or Problem Description
It was learned through implant patient registry that a 19mm 11500a aortic valve in aortic position was explanted and replaced with a 21mm 11060a konect valved conduit after an implant duration of 1 year, 2 months and 14 days due to moderate to severe aortic regurgitation.The patient presented with dyspnea.Intraoperatively, a cavity was noted adjacent to where the right coronary ostium would be.The surgeon noted that this was likely a hematoma secondary to the prior root enlargement.An incredible amount of inflammation was noted throughout the aortic root.A 21mm 11060a valved aortic conduit was sutured into place.There was difficulty coming off cbp and patient was placed on ecmo.Hemostasis was obtained and patient was taken to the icu in critical condition.Patient discharged on pod#3.Per pathology, explanted aortic valve had no vegetations, tears, or calcifications along the valve cusps.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, b5, b7, g3, g6, h2, h6 (type of investigation).
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.Engineering evaluation summary: per (b)(4), regurgitation identified post-procedurally has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Regurgitation occurring during device implantation or post-procedurally is most commonly related to patient and/or procedural factors and is not typically an indication of a device malfunction 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-related factors, including coronary artery disease (cad).All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 21674610
• Report Number: 2015691-2025-02186
• Device Sequence Number: 7600225
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)261026(11)221027
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2025

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: 11500A
• Device Catalogue Number: N/A
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/02/2025
• Initial Report FDA Received Date: 03/23/2025
• Supplement Report FDA Received Date: 04/21/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2022
• 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; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female