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

Model Number	8300AB21A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to edwards for evaluation.H3.Device evaluation: report was of unknown reasons and was unable to be confirmed.X-ray demonstrated frame was expanded, deformed, and pushed inward around commissure 2.Wireform was also exposed around commissure 2.Suture holes were visible near two of the three black stitch markings on the sewing ring; one suture hole near each.Edwards will continue to review and monitor all events.Trends are monitored on a the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was learned through receipt of device in the edwards decontamination lab that a 21mm 8300ab aortic valve was explanted after unknown implant duration due to unknown reasons.The 21mm 8300ab aortic valve was implanted (b)(6) 2024.
Additional Manufacturer Narrative
Added information to h6.A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, 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.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, a definitive root cause cannot be conclusively determined.

• 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21748614
• Report Number: 2015691-2025-02486
• Device Sequence Number: 18495364
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)270830
• 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: 2024
• 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): 06/03/2025

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: 8300AB21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female