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); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is underway.
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, regarding implantation of a 29mm sapien 3 ultra resilia valve in the aortic position.The 29mm commander delivery system balloon ruptured during deployment.There was difficulty withdrawing the 29mm commander delivery system into the 16f esheath plus due to the circumferential balloon rupture.An up and over snare was attempted but it was still not going into the sheath.Finally, the team decided to snare the distal tip and go up and over into a 22 fr sheath from the left side.Once the distal tip was placed into the sheath on the left side, the back of the balloon system (above the y-connector) was cut.The delivery system and half of the balloon was removed from the right.Removed the yellow tip and top of the balloon from the left side.They did notice some limited flow on the right side and had to use a device to remove some clots from the patient.After this procedure the patient had flow and no major issues were noted.The patient left the procedure in stable condition.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections: g3, g6, h2, h6 type of investigation, investigation findings, investigation conclusions 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.Through extensive complaint investigations, balloon burst events during valve deployment have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause of these events has historically been due to calcification in the landing zone or over-inflation of the balloon.The reported balloon burst 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 the customer reported the balloon on the delivery system ruptured during deployment what was thought to be because of stj calcium.Calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.The reported difficulty or inability to withdraw system through sheath 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 procedural factors (withdrawal of burst balloon) likely contributed to the event.As the balloon burst, the altered balloon profile could have made it more susceptible to catching on the distal end of sheath tip, which could have led to the observed withdrawal difficulty.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 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: 24262062
• Report Number: 2015691-2026-10813
• Device Sequence Number: 9550059
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)270911(10)67009313
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/04/2026

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: 67009313
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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 Sex: Male