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

Model Number	8300AB25A
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional narrative.Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.H3: product evaluation.Customer reports of difficulty seating and perivalvular leak were unable to be confirmed through visual observations.As received, leaflet 1 had a 6mm cut near commissure 1 and edges of cut appeared to match up.Reference measurements were taken; the external sewing ring diameter measured to be approximately 30 mm and the stent diameter measured to be approximately 25 mm.X-ray demonstrated wireform intact and frame partially expanded.Frame remained crimped around commissure 2.No other visible inconsistencies were observed on the valve.Suture holes were visible near all three black stitch markings on the sewing ring: one suture hole near each.
Event or Problem Description
It was reported that a 8300ab 25mm aortic valve was explanted on pod #7 due to perivalvular leak.A 8300ab 27mm was implanted in replacement.As reported the sizers had good fit in the annulus, however surgeon stated there was difficulty seating the valve.Per medical records the patient initially underwent avr and cabg x 2.The patient had extensive calcification of the ascending aorta that was removed on the left side.There was good apposition of the valve to the annulus and the patient was transferred to icu in stable condition.Post-operative echo showed perivalvular leak.On pod #7 the patient underwent redo-avr and aortic root enlargement.The leak was found between the right and the left coronary cusp.This was mostly perivalvular leak around the stent of the valve.A new 8300ab valve was used in replacement with good apposition to the annulus.The patient was transferred to icu in stable condition.Per product evaluation customer reports of difficulty seating and perivalvular leak were unable to be confirmed through visual observations.As received, leaflet 1 had a 6mm cut near commissure 1 and edges of cut appeared to match up.Reference measurements were taken; the external sewing ring diameter measured to be approximately 30 mm and the stent diameter measured to be approximately 25 mm.X-ray demonstrated wireform intact and frame partially expanded.Frame remained crimped around commissure 2.No other visible inconsistencies were observed on the valve.Suture holes were visible near all three black stitch markings on the sewing ring: one suture hole near each.
Additional Manufacturer Narrative
H11.Additional narrative: updated h6.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.A device history record (dhr) review was performed, and no relevant non-conformances were identified.There is no evidence to suggest a manufacturing non-conformance contributed to this event.Based on the information available, the most likely root cause is patient factors, including the patient had extensive calcification of the ascending aorta.

• 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: jason reves ; one edwards way; mle fl2; irvine, CA 92614 ; 9492503859
• MDR Report Key: 23992591
• Report Number: 2015691-2026-10233
• Device Sequence Number: 18697718
• Product Code: LWR
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)281204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 01/23/2026

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: 8300AB25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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; Required Intervention; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Male