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

Model Number	8300AB19A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194)
Date of Event	02/19/2024
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 learned via the patient registry that a patient with a 19mm 8300ab intuity valve in aortic position underwent a redo aortic valve replacement procedure after an implant duration of six (6) years, four (4) months and 24 days due to aortic stenosis.The patient initially presented with shortness of breath and dizziness.The explanted valve was replaced with a 25mm 11500a inspiris valve.The patient was noted to be in stable condition post procedure.
Additional Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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, noncalcific 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 related to a manufacturing deficiency.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 capa/scar/pra is not required as there are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including hyperlipidemia (hld).

• 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: 19074941
• Report Number: 2015691-2024-02720
• Device Sequence Number: 6891589
• Product Code: LWR
• UDI-Device Identifier: 00690103194470
• UDI-Public: (01)00690103194470(17)181208
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 05/14/2024
• Device Model Number: 8300AB19A
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/16/2024
• Date Device Manufactured: 12/08/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Female