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

Model Number	8300AB
Medical Device Problem Codes	Perivalvular Leak (1457); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 21mm 8300ab aortic valve implanted for 89 days underwent a valve-in-valve due to pvl with severe aortic regurgitation.The tavr procedure was performed with a 23mm 975rsl valve.The team was satisfied with the outcome.Per medical records, the patient presents with heart failure ef< 20% and acute on chronic renal failure.Patient was admitted pre-op to medically manage acute renal and heart failure/lvad.Aortic valve now with pvl with severe aortic regurgitation.
Additional Manufacturer Narrative
H11.Additional narrative.Updated b3, b5, and h6.
Additional Manufacturer Narrative
Updated section b4 (date of this report).Updated sections g3 (date received by manufacturer), g6 (type of report).Updated sections h2 (if follow-up, what type), h6 - device code(s); type of investigation; investigation findings; investigation conclusions.H11: additional manufacturer narrative: paravalvular/perivalvular leak (pvl) refers to blood flowing through a channel between the sewing ring of the implanted valve and the cardiac tissue due to an insufficient seal of the valve to the annulus.Annular calcification is also a risk factor for the development of peri-operative pvl, as the bioprosthesis may not seat properly after debridement.Technique related factors during implantation, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may also create difficulty seating the bioprosthetic valve, resulting in pvl.There is no evidence to suggest a manufacturing non-conformance contributed to pvl.There is insufficient information available regarding patient or procedural factors known to cause or contribute to pvl.Therefore, a definitive root cause cannot be conclusively determined.Regurgitation is a common manifestation of bioprosthetic valve and valved conduit dysfunction.Common intraoperative factors that may cause or contribute to acute postprocedural regurgitation include device distortion; device interaction with patient anatomy or other devices; leaflet damage, and incorrectly sized valve seated.Non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis may also cause or contribute to acute post-procedural regurgitation.Complaints reported with regurgitation as the primary complaint code are not typically attributed to manufacturing-related nonconformances.There is no evidence to suggest a manufacturing defect caused or contributed to the reported regurgitation.Based on the information available, the most likely root cause is patient factors, including coronary artery disease, chronic kidney disease.A device history record (dhr) review was performed, and no relevant non-conformances were identified.There were no issues identified that would have impacted this event.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.H11: corrected data: corrected section b7 (other relevant history, including preexisting medical conditions).Corrected section h6 - component code; health effect - impact code.
Additional Manufacturer Narrative
Additional manufacturer narrative: the patient is currently under consideration for a reintervention procedure.The subject device is not available for evaluation as it remains implanted in the patient.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 that a patient with a 21mm 8300ab aortic valve has been placed under consideration for a valve-in-valve (savr) procedure after an implant duration of 89 days due to pvl.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492500222
• MDR Report Key: 23000237
• Report Number: 2015691-2025-07383
• Device Sequence Number: 13141604
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)270226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: 8300AB
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/10/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 106 KG