MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS 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	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the edwards field clinical specialist, a patient with a 23mm sapien 3 aortic valve implanted for 5 years and 6 months underwent a valve-in-valve procedure due to significant central aortic regurgitation resulting in heart failure hospitalization.The perceived root cause of the regurgitation was leaflet issues.A 20mm sapien 3 ultra valve was implanted in the failed valve.Upon completion of balloon expansion/valve deployment the commander delivery system balloon ruptured.An extra cc had been added to the balloon.The team decided to not post-dilate as they felt they had a good result due to low gradients and what appeared to be full expansion.The balloon was successfully removed without event.The patient left the room alive and well.
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2025-01174.Investigation is ongoing.
Additional Manufacturer Narrative
Updated section h6- type of investigation, findings, and 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 as it was discarded.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The provided device-related photos and fluoro/cine imagery were reviewed and confirmed the balloon burst.Review of the pre-procedural 3mensio imagery revealed the following: calcification in the landing zone and pre-existing valve leaflets.Per the technical summary, the instructions for use (ifu), current risk mitigations including design and manufacturing controls, 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.Through extensive complaint investigations, balloon burst events during valve deployment have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to calcification in the landing zone or over-inflation of the balloon.The complaint for delivery system balloon burst was confirmed based on review of provided post-procedural device imagery.Available information suggests the patient factors (calcification) and/or procedural factors (overinflation) likely contributed to the event as review of provided 3mensio imagery revealed calcification in the landing zone and on pre-existing valve leaflets.Additionally, it was reported that the degree of calcium in the annulus/leaflets was "moderate/severe" and that "an extra cc was added to the balloon." 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.While the prescribed nominal inflation volume is provided in the ifu, it is possible that extra inflation volume was used (over-inflation), subjecting the balloon to pressures high enough to cause the balloon to burst.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: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 21428096
• Report Number: 2015691-2025-01180
• Device Sequence Number: 12741044
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)260115(10)65544316
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 04/01/2025

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 Expiration Date: 01/15/2026
• Device Model Number: 9750CM20A
• Device Catalogue Number: N/A
• Device Lot Number: 65544316
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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: Female