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

Model Number	9600LDS29A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during deployment of a transfemoral transcatheter aortic valve replacement procedure with a 29 mm sapien 3 valve, the commander delivery system balloon burst during deployment and the valve embolized.During inflation, the balloon ruptured, and blood was observed in the syringe.The valve was not able to be fully deployed and remained approximately 20-30% expanded.The delivery system could not be withdrawn through the partially deployed valve despite multiple attempts.While attempting to maintain wire and valve position during removal, the valve embolized to the descending aorta.Contralateral access was obtained, and a wire was advanced through the embolized valve.A 28 mm true balloon was then advanced over the wire and used to fully deploy the 29 mm valve in the descending aorta.Following this maneuver, the delivery system was removed and a new 29 mm sapien 3 valve was implanted.The patient remained in stable condition at the end of the procedure.No patient injury or major vascular complications were reported.
Additional Manufacturer Narrative
The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.Upon visual examination, it was observed that the inflation balloon was damaged at the proximal side of the working length.Due to the nature of the complaint event, no applicable functional testing was performed.The complaint was confirmed through visual examination.The inflation balloon single wall thickness was measured along the edges of the burst location.A thickness deviating from the specification could be indicative of an issue during manufacturing of the component, as a thin wall could contribute to the observed burst.All measurements met the specification.Regarding the difficulty withdrawing, there was no applicable dimensional testing.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 of the patient anatomy was provided and it was observed that calcification was present in the landing zone.The complaints for balloon leak and difficulty withdrawing were confirmed based on evaluation of the returned device.In this case, review of the anatomical imagery that was provided revealed calcification within the landing zone.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.As the balloon was damaged, the altered balloon profile may have made it more susceptible to catching on the thv during withdrawal from the partially deployed valve, contributing to resistance, the reported withdrawal difficulty, and the resulting valve embolization.As such, available information suggests that patient factors (calcification) may have contributed to the reported balloon damage and subsequent leak, while procedural factors (damaged balloon) may have contributed to the reported withdrawal difficulty and subsequent valve embolization.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, 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: 23795258
• Report Number: 2015691-2025-10146
• Device Sequence Number: 10493914
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)261204(10)66184769
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/20/2026

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: 9600LDS29A
• Device Lot Number: 66184769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male