MAUDE Adverse Event Report: Edwards Lifesciences LLC EDWARDS INTUITY ELITE Valve System; Heart-Valve, Non-Allograft Tissue

Model Number	8300AB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through receipt of medical records, that a patient with a 21mm 8300ab aortic valve implanted had complete heart block requiring permanent pacemaker on pod#2.Per medical records, the patient underwent tavr explant with placement of a 21mm edwards intuity surgical valve.Post-operative course was complicated by chb s/p ppm on pod#2.The patient was discharged home with hh on pod#5.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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 accordinglyupon investigation completion.

• Brand Name: EDWARDS INTUITY ELITE Valve System
• Common Device Name: Heart-Valve, Non-Allograft Tissue
• Manufacturer (Section D): Edwards Lifesciences LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): Edwards Lifesciences LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; +1(949)250-3859
• MDR Report Key: 50015504
• Report Number: 2015691-2026-17115
• Device Sequence Number: 16096779
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 8300AB
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female