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

Model Number	9750CM26A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, during a transfemoral tavr procedure with a 26 mm commander delivery system (ds), the balloon ruptured before the 26 mm sapien 3 ultra resilia (s3ur) valve was 100% expanded.The ds was removed, and a new ds was opened and prepped with +2 cc of extra contrast.Post-dilatation of the s3ur was successful.The physician team believed the balloon ruptured due to leaflet calcium.The patient left the room in stable condition.
Event or Problem Description
Additional information was received from the field clinical specialist: during a transfemoral tavr procedure with a 26 mm commander delivery system (ds), the balloon ruptured before the 26 mm sapien 3 ultra resilia (s3ur) valve was 100% expanded.A balloon aortic valvuloplasty was not performed prior to valve deployment.The balloon rupture was described as a longitudinal tear.The ds was removed, and a new ds was opened and prepped with +2 cc of extra contrast.Post-dilatation of the s3ur was successful.The physician team believed the balloon ruptured due to leaflet calcium.The patient left the room in stable condition.The device was discarded and is not available for return.
Additional Manufacturer Narrative
A supplemental report is being submitted for the additional information received.Sections b.4, g.3, h.6 and h.2 were updated.An addition was made to b.5.A correction was made to h.6: type of investigation.Investigation is ongoing.
Additional Manufacturer Narrative
A supplemental report is being submitted for the completed engineering evaluation.Sections b.4, g.3, and g.6 have been updated.Corrections were made to h.6: type of investigation, investigation findings, and investigation conclusions.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.Imagery provided by the site revealed calcification within 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 complaint for balloon burst was empirically confirmed, as the reported event was consistent with the investigation documented in the edwards technical summary.Available information suggests that patient-specific factors of calcification was the perceived root cause of the balloon rupture.Calcification may 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 may compromise the structure of the balloon wall through mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24650624
• Report Number: 2015691-2026-13366
• Device Sequence Number: 9760757
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)270924(10)67048358
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/04/2026

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: 9750CM26A
• Device Lot Number: 67048358
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/03/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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: Male