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	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist, during a tavr procedure with a 20mm sapien 3 ultra resilia valve, the 20mm commander delivery system balloon ruptured on deployment.The delivery system was successfully removed from body with no patient injury.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information from a product investigation.The following sections of this report have been updated: b.4, g.3, g.6, h.2 and h.6.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 ifu, current risk mitigations include design and manufacturing controls, 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.Review of imagery provided confirmed a fully circumferential balloon burst.Additionally review of patient imagery confirmed the presence of calcification surrounding the pre-existing surgical valve.In this case, balloon burst was able to be confirmed based on photos provided of complaint device.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.Additionally, while the prescribed nominal inflation volume is provided in the ifu, it is possible that extra inflation volume was used during valve deployment, as reports document an alleged +2cc inflation volume over recommended nominal inflation volume used, which may have subjected the balloon to pressures high enough to cause the balloon to burst.Available information from provided patient imaging suggests calcification and pre-existing surgical valve likely contributed to the event.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 (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: 20761215
• Report Number: 2015691-2024-08850
• Device Sequence Number: 9282997
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)251105(10)65430455
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 11/05/2025
• Device Model Number: 9750CM20A
• Device Lot Number: 65430455
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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