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

Model Number	9600LDS29A
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Device Slipped (1584)
Health Effect - Clinical Codes	Arrhythmia (1721); Foreign Body In Patient (2687)
Date of Event	08/18/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist, during a tavr procedure with a 29mm sapien 3 valve, valve alignment was off due to tortuous anatomy.Valve alignment difficulty occurred throughout every location in the abdominal aorta.It was very difficult to find a straight portion for alignment.Issues occurred during fine adjustment.Valve was between the valve markers before we crossed the annulus.After crossing annulus, we attempted to partially inflate then go down on balloon, reposition and finish inflation.The valve became under aligned.It was determined to deploy with the understanding it would be a long pacing run to give time to adjust the balloon after partial inflation.The valve was not deployed in the intended location.Valve slightly embolized aortic (100/0) balloon would not adjust.Inflation was stopped to keep valve from migrating higher in aorta.Long pacing run sent patient into vt (ventricular tachycardia).Could not stabilize the patient after 30 minutes of coding.The patient expired.The valve was stuck on the balloon and traveled back into the femoral artery after the patient expired.The system was cut to get delivery system out of the body.Per clarification from the fcs, the valve was never fully deployed and the stated "valve slightly embolized aortic" was valve movement on balloon.There were withdrawal issues after the case ended.The valve was stuck on the delivery system.Ic cut the delivery system to remove it from the body.The valve was left in the femoral artery.
Additional Manufacturer Narrative
Corrected h6 health effect impact code, health effect clinical code, and device code based on administrative review.Investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information from a product investigation.The following sections of this report have been updated: b.4, g.3, g.6, h.2 and h.6.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.Review of patient imagery provided, showed and acute bend in the descending aorta and tortuosity in the abdominal aorta and access vessels.In this case, valve alignment difficulty was confirmed empirically based on review of provided imagery.Available information suggests that patient factors (tortuosity) and procedural factors (valve alignment in non-straight section) likely contributed to the event as it was reported that ''extreme tortuosity in the patient anatomy would not allow the delivery system to perform the valve alignment.Valve alignment difficulty occurred throughout every location in the abdominal aorta.It was very difficult to find a straight portion for alignment.'' review of provided imagery revealed an acute bend in the descending aorta and tortuosity in the abdominal aorta and access vessels.If valve alignment was performed in a tortuous vasculature (non-straight section), this could have caused the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and ''dive'' into the flex tip.If the thv was unseated from the flex tip during alignment, it could have resulted in higher-than-normal alignment forces creating high tension in the system, which could have consequentially led to the reported valve alignment difficulties.Valve movement on balloon and subsequent patient death was confirmed empirically based on review of provided imagery.Available information suggests that procedural factors (release of built-up tension) likely contributed to the event as it was reported that ''[the] valve was between the valve markers before [crossing] the annulus.After crossing annulus, [.] the valve became under aligned'' and that the valve moved on balloon, towards the aorta.The release of built-up tension within the delivery system during the procedure may have resulted in the reported valve movement on balloon during flex tip retraction.Withdrawal difficulty was confirmed empirically based on review of provided imagery.Available information suggests that patient factors (tortuosity) and procedural factors (withdrawal of partially deployed valve) likely contributed to the event as it was reported that ''the valve was stuck on the balloon and traveled back into the femoral artery''.A partially deployed valve has an increased profile compared to a crimped thv.In this case the increased valve profile may have interacted with patient vasculature during withdrawal, preventing retrieval of the thv through the vasculature.In addition, it is possible that non-coaxial withdrawal may have resulted in the partially-deployed thv interacting with patient vasculature or the sheath, contributing to the withdrawal difficulty.Tortuous patient anatomy can also contribute to non-coaxial withdrawal of the delivery system.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 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: 23039073
• Report Number: 2015691-2025-07530
• Device Sequence Number: 21201513
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)270423(10)66548858
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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: 66548858
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 10/15/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/03/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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 Sex: Unknown