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

Model Number	9750TFX20
Medical Device Problem Codes	Perivalvular Leak (1457); Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by our german affiliate during a transfemoral transcatheter aortic valve replacement (tavr) with a 20mm sapien 3 ultra valve, although the valve was appropriately positioned between the balloon markers prior to deployment, during valve deployment the 20mm commander delivery system (ds) balloon inflated unexpectedly, with the proximal (outflow) portion inflating first while the distal (inflow) portion remained snared with the valve and then abruptly inflating with the proximal balloon part, causing an unpredictable valve deployment.Consequently, the valve was implanted too high in the aortic position, with a higher grade of paravalvular leak observed on final fluoroscopy.The delivery system was subsequently removed without any issues, and no damage was observed on the 14fr esheath+ upon withdrawal.A second valve was then implanted more ventricular which resulted in no paravalvular leak.The procedure was therefore completed successfully.No injury was reported, and the patient was discharged.

• Brand Name: EDWARDS LIFESCIENCES SAPIEN 3 ULTRA TRANSCATHETER HEART 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: 24744942
• Report Number: 2015691-2026-13711
• Device Sequence Number: 9101271
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 9750TFX20
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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 Sex: Unknown