MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US 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	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a field clinical specialist, a patient underwent a transaortic tavr procedure with a 26mm sapien 3 ultra valve in aortic position.During the procedure, the certitude delivery system balloon had ruptured at the end of inflation.The valve was successfully implanted with no major vascular complications.As per follow-up with the fcs, this was a direct aortic approach with existing cutdown.A two-stage deployment was suggested, but the physician proceeded with full volume, and the valve appeared fully expanded on fluoroscopy and echocardiography.The valve was able to be fully deployed.No extra volume was added prior to inflation.Blood was not seen in the syringe, and valve alignment was performed without difficulty in a straight section.Withdrawal of the delivery system was challenging, and the system could not be pulled back into the sheath.No damage was noted to other edwards devices, and there were no patient injuries or complications.The patient was stable and discharged.The perceived root cause was heavy stj calcium.As per follow-up with the vcc, the patient did very poorly post tavr and passed away on post op day 3.The presumed cause of death was noted as multisystem organ failure post tavr, to include arf, probable hit, and respiratory failure.There was no allegation or indication a tavr procedural complications nor the valve caused or contributed to the death.
Additional Manufacturer Narrative
Investigation is ongoing.
Additional Manufacturer Narrative
The event(s) reported is/are 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(s) is not required at this time.The returned device was evaluated and showed a balloon that had burst both radially and longitudinally, with no balloon material missing.A kink was present on the guidewire lumen as it exited the proximal shoulder approximately 2.5 inches from the nose tip, likely related to packaging.The balloon wing was also noted to be flared out.Dimensional testing was performed, and the inflation balloon single wall thickness was measured along the edges of the burst location.The measurements show that the balloon wall thickness was within specification.Due to the nature of the complaint, no functional testing was able to be pcomplaint.Imagery was provided by the site and revealed that there was calcification present in the landing zone.The complaint was confirmed through visual evaluation.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 balloon burst was confirmed based on visual evaluation of the returned product.Available information suggests that patient factors (calcification) likely contributed to the event as 3mensio revealed calcification in the 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.The ifu 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.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.No corrective or preventative actions are required at this time.

• Brand Name: US CERTITUDE 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: 23369702
• Report Number: 2015691-2025-08743
• Device Sequence Number: 21315235
• Product Code: NPT
• UDI-Device Identifier: 00690103201192
• UDI-Public: (01)00690103201192(17)260813(10)65955897
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 64 KG