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

Model Number	9630TA26A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), a device-related event occurred during a transcatheter aortic valve implantation procedure involving a 26 mm sapien 3 ultra valve delivered via a catheter-based delivery system.The procedure was performed via left carotid access in a native tricuspid aortic valve.During valve deployment, the delivery system balloon ruptured during inflation when the balloon was fully expanded.The valve was able to be fully deployed, and the device was successfully implanted.Blood was observed in the inflation syringe at the time of the event.No leakage from the delivery system was otherwise noted, and no damage was identified to other edwards devices used during the procedure.There was no reported difficulty with withdrawal of the delivery system.Additional procedural details include that no pre-dilation (bav) was performed prior to implantation, and approximately 2 cc of additional volume was added to the balloon prior to inflation.Valve alignment was not performed in a straight segment of the anatomy.The annulus demonstrated moderate calcification, including calcium extending from the annulus into the left ventricular outflow tract (lvot), and moderate tortuosity was also noted.The minimum luminal diameter was reported as 24.4 mm.No injury or patient complication was reported in association with this event.The patient was reported to be in stable condition following the procedure and was alive at the conclusion of the case.There was no central leak reported, and the valve functioned as intended post-implant.The device was discarded.
Additional Manufacturer Narrative
Investigation is ongoing.

• Brand Name: EDWARDS CERTITUDE 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: 25210463
• Report Number: 2015691-2026-15312
• Device Sequence Number: 16070518
• Product Code: NPT
• UDI-Device Identifier: 00690103201192
• UDI-Public: (01)00690103201192(17)260813(10)65955897
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/15/2026

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 Expiration Date: 08/13/2026
• Device Model Number: 9630TA26A
• Device Lot Number: 65955897
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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 Age: 76 YR
• Patient Sex: Male