MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 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	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, a commander delivery system balloon burst occurred during implant of a 20mm sapien 3 ultra valve within a conduit in the pulmonic valve.An 18mm non-ew conduit had moderate stenosis and regurgitation.A 20m non-ew balloon was used to assess baseline waist.Conduit dilation was performed with an 18mm non-ew dilation catheter and a 20mm dilation catheter to rbp and coronary testing.A non-ew stent on a 20mm balloon-in-balloon was deployed and post dilated with 20mm non-ew dilation catheter.The stent measured 20mm.A 24fr non-ew sheath was advanced into the main pulmonary artery distal to the stent via the right transfemoral.A 20mm sapien 3 ultra valve and commander delivery system with +3cc above nominal were prepared per physician's request.The valve was aligned on the delivery system under fluoroscopic imaging before being inserted into the patient.During deployment of the valve, the delivery system balloon ruptured at the last couple additional cc of inflation.The delivery system balloon was retrieved into the sheath without complication.The balloon appeared intact with a radial burst noted.Post angiography confirmed normal leaflet function and catheter gradient post peak to peak measured 18mmhg.Post intracardiac echocardiography imaging demonstrated good leaflet function with no leak and peak to peak gradient through the valve of 30mmhg.There was no patient injury or complications.The case was considered a success.The perceived root cause of the event is unknown.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information based on the engineer evaluation.The following sections of this report have been updated: additional codes added to h6 type of investigation, corrected h6 investigation findings, and corrected h6 investigation conclusions.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 discarded and 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.Device imagery was reviewed and the following was noted: balloon has a fully circumferential radial burst.No missing pieces observed.The sapien 3 ultra valve appears fully deployed within a conduit.The instructions for use (ifu), and training manuals have been reviewed.However, the commander delivery system with sapien 3 ultra (s3u) transcatheter heart valve is not currently indicated for implantation in the pulmonic position.Therefore, this case represents an off-label procedure.The training materials of implantation of a sapien 3 (s3) transcatheter heart valve in the pulmonic position were reviewed to identify relevant guidance applicable to a s3u implant using the commander delivery system (ds) and gore dryseal sheath.No inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The delivery system balloon burst was confirmed based on the provided imagery.Per review of provided device-related imagery, the balloon was fully circumferentially and radially burst.In this case, an additional 3ml of inflation volume was added to the balloon prior to valve deployment.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.As such, available information suggests that procedural factors (over-inflation) likely contributed to the complaint event.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: 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: 24913212
• Report Number: 2015691-2026-14458
• Device Sequence Number: 9800067
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)271103(10)67182108
• 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): 05/21/2026

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: 67182108
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 49 KG