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

Model Number	9750CM23A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist, a transfemoral transcatheter aortic valve replacement (tavr) was performed via the right femoral access to implant a 23 mm sapien 3 ultra transcatheter heart valve (thv) in the aortic position.The patient is a (b)(6) year old female.During valve deployment, a balloon issue occurred on the delivery system.Specifically, the inflation balloon ruptured during inflation, resulting in partial valve deployment (~95%).The procedure team noted blood in the syringe consistent with balloon rupture.There was no leakage observed from the delivery system and no difficulty with valve alignment (alignment performed in a straight section of the anatomy) or with withdrawal of the delivery system.Balloon shaft damage was reported; no additional damage to other edwards components (e.G., flex shaft or sheath) was noted.In response to the balloon rupture and partial deployment, the delivery system was removed, and a 22 mm non-edwards balloon was advanced and inflated to complete deployment of the thv.A pre implant bav was not performed, and no extra volume had been added to the edwards deployment balloon prior to inflation.The valve was successfully implanted, and there was no central leak reported.The patient had no injury or procedural complications related to the event and was reported in stable condition at the end of the case.Anatomical and procedural context included moderate annular/leaflet calcification, mild tortuosity, an annulus size of 400mm, and a minimum luminal diameter of 21mm.The perceived root cause reported by the site was calcification at the sinotubular junction (stj calcium) contributing to balloon rupture during inflation.The edwards delivery system is not available for return as the delivery system was discarded.
Additional Manufacturer Narrative
Investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h11 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 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.The complaint for balloon burst was confirmed based on the provided fluoro imaging.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported, 'during valve deployment, a balloon issue occurred on the delivery system.Specifically, the inflation balloon ruptured during inflation, resulting in partial valve deployment (~95%).The procedure team noted blood in the syringe consistent with balloon rupture.There was no leakage observed from the delivery system and no difficulty with valve alignment (alignment performed in a straight section of the anatomy) or with withdrawal of the delivery system.Balloon shaft damage was reported; no additional damage to other edwards components (e.G., flex shaft or sheath) was noted.Per additional follow-up, anatomical and procedural context included moderate annular/leaflet calcification, mild tortuosity, an annulus size of 400mm, and a minimum luminal diameter of 21mm.The perceived root cause reported by the site was calcification at the sinotubular junction (stj calcium) contributing to balloon rupture during inflation.' it was reported that the perceived root cause was calcification at the sinotubular junction (stj calcium) contributing to balloon rupture during inflation.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.As such, available information suggests that patient factors (calcification) may have contributed to the complaint event.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; CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24670825
• Report Number: 2015691-2026-13447
• Device Sequence Number: 12041558
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)271029(10)67143578
• 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): 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: 9750CM23A
• Device Lot Number: 67143578
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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: Female