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

Model Number	9750TFX26A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), 3 years, 6 months, and 23 days post-implant of a 26mm sapien 3 ultra valve in the pulmonic position within a failed 25mm magna ease, the 26mm sapien 3 ultra valve required intervention due to stenosis.The peak gradient was 49mmhg and mean gradient was 30mmhg.The patient was experiencing exercise intolerance, shortness of breath, fatigue and chest pain, hypoxia with minimal activities.The operator ballooned with a true balloon and then implanted the 23mm sapien 3 ultra resilia without complication.The patient was sent to recovery and subsequently discharged.According to the medical records, the patient was experiencing progressive shortness of breath and fatigue with activities and cardiac exam was significant for lower hypoxemia with lower preductal sp02.An echocardiogram showed increased gradient on the sapien valve/pulmonary stenosis and subjectively decreased right ventricle (rv) systolic function compared to prior.A tte was provided that showed the neo-pulmonary sapien valve, mean gradient of 30mmhg, and mild insufficiency.Another tte s/p transcatheter pulmonic valve replacement (tpvr) showed no significant pulmonary stenosis and no pulmonary regurgitation.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Common Device Name: PULMONARY 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: 25578711
• Report Number: 2015691-2026-16213
• Device Sequence Number: 14740826
• Product Code: NPV
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250420
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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 Expiration Date: 04/20/2025
• Device Model Number: 9750TFX26A
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• 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
• Patient Age: 14 YR
• Patient Sex: Male