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

Model Number	9750CM29A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/10/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by our field clinical specialist (fcs) during a transfemoral transcatheter aortic valve replacement (tavr) the devices were prepped per the instruction for use (ifu).The valve was properly aligned and pushed to aortic valve.It appeared some resistance was met with the first attempt at crossing, a second attempt at crossing was made and the valve dove completely across the native valve.The valve was pulled back, placed in proper position at bottom cusps in co-planar view and deployed in 95/5 position.The perceived root cause of the difficulty crossing was calcified leaflets.An echo was performed showing no aortic insufficiency (ai), paravalvular leak (pvl), or effusion.A root shot was performed with left and right coronary artery appearing to fill normally.The patient developed st wave changed and echo was again performed showing a new pericardial effusion.The patient became unstable; the chest was opened and subsequently went into cardiac arrest and was pronounced dead.The guidewire position was maintained during crossing, the valve landed in the intended position, there were no difficulties during valve alignment, and the valve was between markers before valve deployment.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and conclusions in this section have been updated.The event reported is 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 mode 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, the ct showed that there was calcification present in the native leaflets.Through extensive complaint investigations, difficulty or inability in tracking the delivery system to the landing zone, including traversing the aortic arch and crossing the native annulus/bioprosthesis has not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to patient factors, poor guidewire management, damaged guidewire, and/or excessive manipulation of the flex wheel.The complaint for difficulty to cross native annulus has been confirmed based on the information available to date.Any updates or additional findings will be submitted in accordance with fda reporting requirements.Available information suggests that patient factors (calcification) likely contributed to the event as review of provided ct revealed calcified leaflets.Patient factors (i.E.Calcification) may cause constrained sections of the anatomy that interfere with passage of the delivery system and cause difficulty during crossing.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: 24756846
• Report Number: 2015691-2026-13755
• Device Sequence Number: 21123482
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271009(10)67097638
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/29/2026

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: 9750CM29A
• Device Lot Number: 67097638
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Male