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

Model Number	8300AB
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a patient with a 25mm 8300ab aortic valve was explanted after an implant duration of 2 years, 2 months due to unknown reason.The explanted valve was replaced with a 23mm 11500a valve.The patient was in recovery post procedure.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.
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 through implant patient registry and investigation that a patient with a 25mm 8300ab aortic valve was explanted after an implant duration of 2 years, 2 months due to endocarditis (strep sanguinis).The explanted valve was replaced with a 23mm 11500a valve.The patient was in recovery post procedure.Per medical records, the patient presented with epigastric pain, dyspnea and generalized weakness, and was initially diagnosed with renal infarcts, strep sanguinis bacteremia and endocarditis.Patient was started on iv antibiotics.The patient underwent redo-avr with a 23mm 11500a valve.Intraoperatively, the prosthetic av leaflets are severely thickened, with mobile echo densities seen involving the non-coronary and left coronary cusps.The patient tolerated the procedure well, and recovered in the icu.Pod #4 echo showed a well seated av with no regurgitation.
Additional Manufacturer Narrative
Manufacturer narrative: updated sections: b5, b7, d4 expiration date, g3, g6, h2, h4, h6 health effect - clinical code, device code(s), type of investigation, investigation findings, and investigation conclusions.A device history record (dhr) review is not required because 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 device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Intermediate/late onset endocarditis (i.E.Greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patient's body and is not in any way related to the sterilization or packaging process of the device.The microorganism for intermediate/late onset prosthetic device endocarditis may be due to hospital-acquired infections of lower pathogenicity or community-acquired infections.Common sources of endocarditis include dental, surgical, or endoscopic procedures; iv drug abuse; or recurrent endocarditis.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely cause is patient factors.Corrected data: based on the additional information, this event is no longer considered reportable and this correction is being submitted.

• 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 ; 9492506615
• MDR Report Key: 21194367
• Report Number: 2015691-2025-00408
• Device Sequence Number: 8599089
• Product Code: LWR
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)260328
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 03/28/2026
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2022
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male