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

Model Number	9750CM20A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a right transfemoral tavr procedure with a 20m sapien 3 ultra resilia valve, the in-sheath dilator was inserted about halfway before stopping with a lot of resistance in the optima sheath.The operator requested a standard 14f esheath+ to be opened.A new 20mm sapien 3 ultra resilia valve was prepped at +1cc.The push force was very high going through the expandable part (blue part) of the 14fr esheath+, but eventually advanced successfully.Upon deployment when valve was approximately 95-100% deployed, the balloon on the 20mm commander delivery system burst.The delivery system was successfully retrieved through esheath+.A 20mm true balloon was prepped and used to post dilate the valve to assure the valve was fully expanded.There was no injury to the patient with good final results.Per report, the minimum vessel diameter of the right common femoral was 5.8mm, and the right vessel was successfully dilated using 16f dilator.
Additional Manufacturer Narrative
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 returned for evaluation.The returned device was visually evaluated, and the following was observed: the balloon burst longitudinally and radially.No missing balloon material.Dimensional testing the inflation balloon single wall thickness was measured along the edges of the burst location.Measurements met the specification.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.The 3mensio imagery was provided and the following were observed: calcification was present in the landing zone.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 event for balloon burst was confirmed based on evaluation of the returned device.Available information suggests patient (calcification) likely contributed to the event.The presence of 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.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: 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: 22206821
• Report Number: 2015691-2025-04863
• Device Sequence Number: 12693619
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)270303(10)66352238
• 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): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9750CM20A
• Device Lot Number: 66352238
• Was Device Available for Evaluation?: Yes
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sex: Unknown