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

Model Number	8300AB21A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve additional information is in process.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 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 21mm 8300ab aortic valve implanted three (3) years, eight (8) months, is being evaluated for valve-in-valve procedure due to leaflet calcification.
Additional Manufacturer Narrative
Added information to b2, b5, b6, b7, h6.
Event or Problem Description
It was reported a patient with a 21mm 8300ab aortic valve implanted three (3) years, eight (8) months, underwent valve-in-valve procedure due to leaflet calcification and severe aortic stenosis.Patient presented with exertional dyspnea and nyha class ii symptoms.Tavr was performed with a 23mm non-edwards transcatheter valve.Patient was taken to the recovery unit in stable condition and was discharged on pod #2.
Additional Manufacturer Narrative
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.Calcific degeneration involves the gradual accumulation of calcium deposits on the valve leaflets.It is a disease continuum from sclerosis to chronic inflammation that leads to leaflet calcification.These calcium deposits, over time, cause the leaflets to become rigid and less flexible, which can account for failure modes such as stenosis and regurgitation.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.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."" the instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A dhr review was performed, and no related manufacturing nonconformances were identified.There is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.The most likely cause is patient factors, including hyperlipidemia (hld), diabetes mellitus (dm),.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20696543
• Report Number: 2015691-2024-08659
• Device Sequence Number: 17106368
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)230930
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 8300AB21A
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/08/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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; Required Intervention; Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Female