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

Model Number	9630TA23A
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), the patient was undergoing a transcarotid valve-in-valve transcatheter aortic valve replacement (tavr) procedure using a 23 mm sapien 3 ultra resilia valve.The valve was being implanted inside a non-edwards valve.During the procedure, there was resistance when advancing the certitude delivery system with valve through the 21fr certitude sheath, but the delivery system with valve was able to exit the tip of the sheath.After exiting the tip of the sheath, there was difficulty advancing the delivery system through the struts of the non-edwards valve.It was noted that the implanting team was behind the struts of the non-edwards valve.The delivery system crossed the struts at the mid valve part of the valve and was on the outside of the non-edwards valve.The sheath was pulled back and then the sheath was used to provide more support when it was noticed that the tip of the certitude sheath had "broke off".The tip of the sheath was noted to be stuck around the sapien 3 ultra resilia valve.The valve was not deployed.The delivery system with valve and sheath were removed as a single unit.A new 21fr certitude sheath and 23 mm certitude delivery system was prepared along with a 23 mm sapien 3 ultra valve.Prior to the second implant attempt, the non-edwards valve was pre-dilated using an 18 mm balloon as it was believed that the leaflets of the non-edwards valve were heavily calcified.There were no issues advancing the new certitude delivery system and valve through the new certitude sheath.The 23 mm sapien 3 ultra valve was then deployed.There was no valve movement on the delivery system balloon; however, during valve deployment, the delivery system balloon ruptured possibly due to interaction with the struts of the non-edwards valve.An angiogram was performed and it showed no paravalvular leak (pvl) and no rupture.The cath gradient was 0 mmhg.Subsequently, the delivery system and sheath were removed without any issues and the left carotid cutdown was closed.The patient was transferred to the intensive care unit (icu) in stable condition.It was noted that there was no patient injury and the patient was stable throughout the procedure.Additional information was received from the fcs.Per the fcs, there was no damage observed on the first certitude delivery system.It was noted that during the procedure, the wire was going through the center at the top of the non-edwards valve, but at some point, the wire ended up behind and on the outside of the non-edwards valve at the basal annular area.It was unknown how this had occurred.The patient remained stable throughout the procedure.On the following day after the procedure, the gradient was 6 mmhg with no pvl, no aortic insufficiency (ai)/aortic regurgitation (ar).The patient was discharged home.Imagery was received for evaluation.Per imaging evaluation of the first system used, the distal tip of the certitude sheath was observed to be separated and shifted distally from the shaft with the shaft coil stretched around the crimped valve.The separated tip remained just distal to the crimped valve on the balloon.The marker band was visible at the proximal portion of the separated tip.Folds were visible on the shaft.The distal end of the certitude delivery system partially exited beyond the sheath tip.No other abnormalities were observed on the delivery system.The valve was noted to be exposed through the sheath shaft and was wrapped by metal braiding, which is from the sheath.No abnormalities were observed on the valve.Per evaluation of the procedural video of the first system used, the video shows the sheath advancing over the crimped valve.The distal tip still remains intact in the video.No procedural imagery was provided of the tip separation or steps after (device withdrawal).The delivery system with crimped valve was partially retrieved into the sheath.It was noted that the valve was smoothly retrieved into the sheath.No abnormalities were observed on the delivery system and valve.Per evaluation of the procedural video of the second system used, prior to valve deployment, the transcatheter heart valve (thv) was not crimped between the two internal balloon shoulders.Balloon inflation was initially constrained at the proximal end, but constraint was eventually overcome, and full inflation was achieved.At the end of the deployment cycle, the thv was fully expanded but not centered between the internal shoulders.A loss of contrast was observed at the end of valve deployment, suggesting a balloon burst occurred.No abnormalities were observed on the valve.Calcification was present at the annulus and sinotubular junction (stj).No abnormal tortuosity or severe calcification were observed on the left carotid access.
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.The investigation is ongoing.

• Brand Name: EDWARDS 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: 24703096
• Report Number: 2015691-2026-13571
• Device Sequence Number: 10176567
• Product Code: NPT
• UDI-Device Identifier: 00690103201185
• UDI-Public: (01)00690103201185(17)270403(10)66490478
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/04/2026

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: 9630TA23A
• Device Lot Number: 66490478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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 Age: 66 YR
• Patient Sex: Male