MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9750CM20A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral tavr (transcatheter aortic valve replacement) procedure with a 20mm sapien 3 ultra resilia (s3ur) valve in the native aortic position, the balloon to the 20mm commander delivery system (ds) burst during valve deployment, possibly due to sinotubular junction calcium.It was noted that an additional 2cc was added to the balloon prior to inflation of the valve.As the valve was under-expanded, it began to migrate towards the left ventricle.The ds was then withdrawn from the patient through the 14fr esheath+ while leaving the esheath+ in place.Per report, there was no separation of the balloon components.A second 20mm s3ur valve was implanted, eliminating any paravalvular leak, and there was no injury to the patient.The ds is available for return/evaluation.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• 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: 24506506
• Report Number: 2015691-2026-11723
• Device Sequence Number: 9870014
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)261007(10)66077754
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 9750CM20A
• Device Lot Number: 66077754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Female