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

Model Number	9600LDS29A
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), a transcatheter aortic valve replacement (tavr) procedure was performed on a patient using a 29 mm edwards sapien 3 valve in the aortic position.The procedure was conducted via transfemoral access, and the valve was successfully implanted.The patient remained in stable condition and was discharged following the procedure.No central leak was observed, and no patient injury occurred.During valve deployment, the balloon "ruptured" at the point of maximum inflation.Despite the "rupture", the full nominal volume was delivered, resulting in a moderate leak and a mean gradient of 5 mmhg.A second delivery system was prepared, and the balloon was inflated to full volume, which resulted in a mild to trace leak with the same gradient.The delivery system was removed without difficulty through a 16 french sheath, and all components were accounted for.The balloon remained intact upon removal.The physician indicated that the rupture was most likely caused by calcium at the sinotubular junction (stj) catching the shoulders of the balloon.No instruments were used to remove the balloon cover, and no leak was observed in the delivery system.Blood was not seen in the syringe, and valve alignment was performed without difficulty in a straight section of the anatomy.No damage was noted to other edwards devices, including the flex shaft, balloon shaft, or sheath.The area of leakage was identified upon inspection after removal.The balloon issue was classified as p3-type damage (balloon leakage).A 3mensio report was provided, supporting the anatomical assessment.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to pre-decontamination engineering evaluation findings, sections g6, h2, h6: device code, type of investigation code.Investigation is still ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, h6: component code, type of investigation, investigation findings, investigation conclusions and h11 narrative has been added.The event(s) reported is/are anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode(s) is not required at this time.The device was returned for evaluation.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 complaint for balloon burst was confirmed based on the returned product evaluation.Available information suggests that patient factors (calcification) likely contributed to the event as the customer reported that the patient had a 'calcified stj'.Also, 3mensio showed calcification was present in landing zone.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.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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: 23000241
• Report Number: 2015691-2025-07384
• Device Sequence Number: 9519919
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)270324(10)66435125
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 11/10/2025

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: 9600LDS29A
• Device Lot Number: 66435125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 11/08/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/02/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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