MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9600TFX20A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist (fcs), during a tmvr procedure with a 20mm sapien 3 valve, the valve had mild to moderate mitral regurgitation (mr) post-implant.The ic decided to post-dilate which unfortunately made the mr worse, so made the decision to re-valve this patient's mitral valve.A second 20mm sapien looked great with no leak and 2mmhg gradient.Per additional information provided by the fcs, it is unknown whether the regurgitation was pvl or central.''there could have been a bit of ''frozen leaflet'' happening, which was the cause for the leak.'' the fcs indicated the root cause could be due to a ''small valve, perhaps under deployed.'' the patient had moderate annular calcification with a 17mm minimum luminal diameter.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information from a product investigation.The following sections of this report have been updated: b.4, g.3, g.6, h.2 and h.6.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure modes are not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the instructions for use (ifu), training manuals and current risk mitigations have been reviewed.No inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaints for regurgitation unknown and leaflet motion restricted were confirmed according to the fcs report.According to the technical summary, extensive investigations have confirmed that no device malfunctions or manufacturing nonconformances were involved in the reported failures.It is possible that one or more patient/procedural factors identified in the technical summary may have contributed to the complaint event.However, due to insufficient information, a definitive root cause cannot be determined.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 22115781
• Report Number: 2015691-2025-04295
• Device Sequence Number: 12556738
• Product Code: NPT
• UDI-Device Identifier: 00690103194005
• UDI-Public: (01)00690103194005(17)270201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9600TFX20A
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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: Required Intervention
• Patient Sex: Unknown