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

Model Number	9750CM26A
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Codes	Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
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) during a transcarotid transcatheter aortic valve replacement (tavr) with a 26mm sapien 3 ultra resilia valve, there was +1cc added to the atrion, upon inflation of the 26mm commander delivery system (ds) balloon, during valve deployment, the balloon ruptured.The decision was made to bring the 14f esheath+ and ds out as a unit, so a second sheath and ds were prepped and the atrion was filled with nominal volume.When the sheath was removed it was noticed there was damage observed at the distal end of the sheath, the distal tip was split.The initial sheath and ds were removed from the patient and the second sheath and was inserted followed by the second ds.The valve was then post dilated.The carotid artery needed surgical repair, which was successfully completed by the surgeon.The perceived root cause of the balloon rupture was stj calcium.The second sheath and ds were then removed.The valve was successfully implanted, and the patient is in stable condition.
Additional Manufacturer Narrative
The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure modes is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the instructions for use (ifu), training manuals and current risk mitigations have been reviewed.No inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Imagery was provided and showed the presence of calcification in the landing zone.Through extensive complaint investigations, balloon burst events during valve deployment have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to calcification in the landing zone or over-inflation of the balloon.The complaint for balloon burst was confirmed through the provided imagery.Available information suggests patient factors (calcification) and/or procedural factors (over inflation) likely contributed to the event as calcification was present in the landing zone and it was reported that ''there was +1cc added to the atrion, upon inflation of the 26mm commander delivery system (ds) balloon.'' the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Additionally, while the prescribed nominal inflation volume is provided in the ifu, over-inflation can expose the balloon to pressures high enough to cause it to burst.The complaint for difficulty to withdraw system through sheath was confirmed based on the provided imagery.Available information suggests procedural factors (withdrawal of burst balloon) likely contributed to the event as the complaint device had a burst balloon and the balloon wing tips appeared to have flared out.As the balloon had burst, the altered balloon profile may have made it more susceptible to catching on the 'distal end of sheath tip, which could have led to the observed withdrawal difficulty.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS LIFESCIENCES 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: 24894551
• Report Number: 2015691-2026-14393
• Device Sequence Number: 8951666
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)271124(10)67220634
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 67220634
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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: 85 YR
• Patient Sex: Male