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

Model Number	9610TF29
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a right transfemoral transcatheter aortic valve replacement (tavr) with a 29mm sapien 3 ultra resilia valve, the 29mm commander delivery system (ds) with the crimped valve was advanced through the 16 esheath+.Final assembly of the valve was done in the descending aorta.The system was manipulated across the arch with the flexing mechanism.Once across the aortic valve, the pusher was retracted back.Aortic injection was performed to confirm proper positioning of the valve.With rapid pacing, aortography was performed to once again confirm positioning, and the balloon was slowly inflated to deploy the valve, pacemaker loss of capture occurred and the valve dislodged proximally.The ds was used to drag the valve into the ascending aorta.The valve was post dilatated successfully anchoring it in place, but the ds balloon ruptured.The ds could not be removed from the sheath initially due to some withdrawal difficulty.The ds was eventually removed but caused a tear in the common femoral artery.Using the left femoral access, a rim catheter was placed and access obtained into the right common iliac.A versa core wire was placed and a 16 mm balloon was inflated to the right common iliac to obtain hemostasis.A cutdown was performed and hemostasis was achieved.A new 16 french sheath was placed and crossed the valve 1 more time.Edwards tavr valve deployment system was introduced into the right common femoral artery and new 29 mm edwards resilia valve was successfully deployed in the aortic annulus.The original edwards aortic valve was fixed in the distal ascending aorta and zone 0 of the aortic arch with excellent flow into the innominate artery.The right common femoral artery was surgically repaired using a patch.The left common femoral artery was perclose successfully.The left common femoral vein was kept in place.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections d4, g6, h4, h2, h6: type of investigation, investigation findings, investigation conclusions and conclusions in this section have been updated.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure modes are 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.The instructions for use (ifu), and training manuals 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 received and evaluated; the inflation balloon material appeared bunched towards the distal end of the balloon, a balloon burst was potentially observed along the edge, the proximal ends of the balloon wings were flared outward, indicating a possible tear at the inflation to crimp bond, the proximal end of the crimp ballon was not visualized in the available imaging, which may indicate that it was obscured by the flex shaft.The complaints for difficulty to withdraw system through sheath and balloon torn were confirmed based on provided imagery.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As the balloon burst, the altered balloon profile could have made it more susceptible to catch on the distal end of the sheath tip, which would have then led to the experienced retrieval difficulty.Additionally, additional pull force or device manipulation applied to overcome withdrawal difficulty may have led to the reported balloon tear.As such, available information suggests that procedural factors (withdrawal of a burst balloon) likely contributed to the withdrawal difficulty and procedural factors (device manipulation) may have contributed to the balloon tear, respectively.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: 24324556
• Report Number: 2015691-2026-11039
• Device Sequence Number: 13142603
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271014(10)67117917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/19/2026

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: 9610TF29
• Device Lot Number: 67117917
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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: 75 YR
• Patient Sex: Male