MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	8300AB27
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
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.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 a patient with a 27mm 8300ab aortic valve implanted six (6) years, underwent valve-in-valve procedure due to severe aortic stenosis.Tavr was successfully performed with a 23mm s3ur transcatheter valve.Patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Added information to b5, b7, h6.
Event or Problem Description
It was reported a patient with a 27mm 8300ab aortic valve implanted six (6) years, underwent valve-in-valve procedure due to severe aortic stenosis and severe aortic insufficiency.Patient presented with shortness of breath.Tavr was successfully performed with a 23mm s3ur transcatheter valve.Patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Added information to h6.The device history record (dhr) review 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.Stenosis is a common manifestation of bioprosthetic valve and valved conduit dysfunction and has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Bioprosthetic device stenosis 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.The most likely root cause is patient factors, including coronary artery bypass graft.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22688862
• Report Number: 2015691-2025-06243
• Device Sequence Number: 12824656
• Product Code: LWR
• UDI-Device Identifier: 00690103194517
• UDI-Public: (01)00690103194517(17)220202
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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
• Device Expiration Date: 02/02/2022
• Device Model Number: 8300AB27
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/03/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/09/2025
• Date Device Manufactured: 02/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male