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

Model Number	9750CM26A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist (fcs), a patient underwent a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 26mm sapien 3 ultra resilia valve in aortic position.During the procedure, the balloon ruptured at the very end of valve deployment.The delivery system was able to be extracted from the sheath without issue.Patient remained stable without paravalvular leak or elevated gradient, and no post-dilitation needed.There were no other complications.As per follow-up with the fcs, the valve was able to be fully deployed in the intended position.No instruments were used to remove the balloon cover, as it remained attached and was safely removed from the patient through the sheath.A bav was not performed prior to implant.An additional 2 cc of volume was added to the balloon before inflation.No leak was observed in the delivery system, but blood was seen in the syringe.There were no difficulties with valve alignment, which was performed in a straight section, and no damage was noted to any other edwards devices.The event did not result in any patient injury or complication.The perceived root cause of the balloon burst was unknown; although the patient had a small amount of lvot calcium, the team agreed it was not significant enough to have caused the rupture.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• 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: 24689639
• Report Number: 2015691-2026-13510
• Device Sequence Number: 18617738
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)271022(10)67140497
• 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
• 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): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 67140497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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
• Patient Age: 84 YR
• Patient Sex: Male