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

Model Number	9750CM29A
Medical Device Problem Codes	Difficult to Remove (1528); Device Slipped (1584); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is two of two manufacturer reports being submitted for this case.The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 29 mm sapien 3 ultra resilia valve in the aortic position, there was difficulty introducing the commander delivery system into the 16f esheath+.It was stuck at the blue portion (sheath shaft/ fully expandable) of the sheath.The esheath was inserted and the vessel was pre-dilated to 18f.The valve and delivery system were advanced in normal fashion until some resistance was met.Both the implanting cardiologist and cardiothoracic surgeon had difficulty pushing the device and fluro showed some buckling above the femoral head so the push/pull method was utilized and the valve with delivery system started advancing until it met more resistance in the external iliac.At that point they could not advance the system anymore and the decision was made to take everything out as a whole and start fresh.They tried pulling the valve/delivery into the sheath more and ended up stripping the delivery system with the pusher off of the valve to where the valve was then on the balloon shaft.The valve and delivery system was stuck in the esheath+ which was inside of the external iliac.It never exited the sheath.The system was stuck in the iliac and would not move at all.At this point it was decided to call in vascular surgery and have them remove the device as a whole.The vascular surgeon piecemealed the removal of the device after the surgical cutdown was performed.The surgeon ended up pulling the sheath out in separate pieces, cut the delivery system and pulled the valve down to the femoral artery where it was then removed.The patient was in stable condition following the unsuccessful implant.The tavr was aborted and they will address the aortic valve at a later time.Damage was noted to both the esheath+ and the delivery system with kinks.The delivery system and valve did not exit the tip of the esheath+.During pre decontamination, a balloon tear at the ic bond was noted.
Additional Manufacturer Narrative
The product was returned; therefore, a product evaluation was completed.Due to the nature of the complaint event, no applicable functional or dimensional testing were completed.The returned device was visually examined, and the following was observed: strain relief bunching on the proximal region.Balloon torn at the ic bond.The crimped valve was located on the proximal inflation balloon shoulder and exhibited a deformed frame, which may be associated with the reported manipulation during removal from the patient.Inflation balloon appears to be bunched up.The provided 3mensio imagery was reviewed, and the following was observed: tortuosity and calcification observed in the left access vessel.The commander delivery system ifu was reviewed.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.' the complaints for thv moves on balloon and balloon torn are confirmed based on evaluation of the returned device.Evaluation of the returned product showed that the device conforms to specifications.However, the complaint for system component damaged was unable to be confirmed due to the condition of the returned device.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.Evaluation of the returned device showed that the device was cut at the distal end, where the balloon shaft and guidewire lumen were located.The associated sheath was also cut and exhibited multiple areas of damage.The crimped valve was located on the proximal inflation balloon shoulder, with the inflation balloon bunched up distal to the valve, and the delivery system balloon was torn at the ic bond.In this case, push-pull maneuvers performed to overcome resistance during system advancement may have caused the crimped valve to move distally.As such, available information suggests that procedural factors (device manipulation) may have contributed to the reported valve movement on the balloon.Per evaluation of the returned device, the distal end of the delivery system was cut at the balloon shaft and guidewire lumen.No kinks or other damage (aside from the balloon tear) were observed.Applying high push force or torsional stress on the commander delivery system can deform system components, leading to kinks in the guidewire lumen, flex catheter, or balloon catheter during advancement through the sheath.As such, available information suggests that procedural factors (high push force and device manipulation) may have contributed to the reported kink, although no kink could be confirmed during evaluation of the returned device due to the returned condition.In cases where the push force is excessive or the valve becomes stuck, the edwards procedural training manuals instruct the user to withdraw the delivery system with the crimped thv and sheath from the patient as a single unit.In this case, the user attempted to withdraw the delivery system with the crimped valve further into the sheath prior to the removal attempt.Given the observed valve movement on the balloon, the system would've had a larger profile, potentially further contributing to the system becoming stuck within the sheath.If additional device manipulation was applied in an attempt to free the system and valve, this may have contributed to tearing of the balloon at the ic bond.The 'popping' sound heard during withdrawal may have indicated a balloon tear.As such, available information suggests that procedural factors (device manipulation) may have contributed to the observed balloon tear.The ifu and training manuals have been reviewed, and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.An investigation has been opened to determine the root cause and implement any necessary corrective actions.

• 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: 24589131
• Report Number: 2015691-2026-13169
• Device Sequence Number: 9377341
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 67182122
• Date Returned to Manufacturer: 02/25/2026
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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: 77 YR
• Patient Sex: Male