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

Model Number	9755RSL26A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is underway.
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, during implantation of a 26mm sapien 3 ultra resilia valve in the mitral position.During inflation, the 26mm sapien 3 ultra resilia valve began to migrate atrial, and paravalvular leak was noted.To prevent further migration, an additional 2 cc was added to the 26mm commander delivery system for a second deployment attempt.However, the additional 2 cc could not be transferred into the delivery system balloon.A third attempt was made to post dilate, but again the balloon could not be fully filled with contrast, and complete inflation could not be achieved.At this point, a second 26mm commander delivery system was prepared with a total of 28 cc of 15 percent contrast using the same atrion syringe and contrast mixture as the first 26mm commander delivery system.Due to the persistent pvl, the team decided to implant a second 26 mm sapien 3 ultra resilia valve.The second valve was deployed successfully, resulting in resolution of the issue.

• Brand Name: SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• Common Device Name: PROSTHESIS, MITRAL VALVE, 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: 25235799
• Report Number: 2015691-2026-15391
• Device Sequence Number: 10289817
• Product Code: NPU
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)281214(11)251215
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: 9755RSL26A
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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: 8 MO
• Patient Sex: Female