MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

As reported from an edwards lifesciences field clinical specialist, frame damage of a 26mm sapien 3 ultra valve occurred, and the valve was implanted.During a right transfemoral tavr procedure, there was difficulty advancing the 26mm commander delivery system and 26mm sapien 3 ultra valve through the 14fr esheath+.The patient was obese, and the sheath was in the body up to the hub.The sheath was kinking just after the hub, which was thought to be due to the patient's body habitus.The operator backed the sheath up slightly and straightened it out, which allowed the delivery system and valve to advance freely.The valve was advanced into the thoracic aorta, and it was noticed that a strut was displaced and sticking out from the side of the crimped valve.After discussion with the physicians, the decision was made to implant the valve in the annulus.The valve was deployed successfully, and the patient was stable during the entire procedure.Imaging was taken post implant of the aortic arch/descending aorta and the iliac arteries which appeared unaffected.Upon removal of the sheath, multiple areas where the valve frame appeared to pierce the sheath were observed.

Manufacturer Narrative

Investigation is ongoing.Device remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: corrected h.6 component code, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions.The sapien 3 ultra valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided for review and revealed the following: imagery was provided by the site and the following was observed.Crimped valve: multiple bent struts at inflow side observed prior to deployment.Post-expanded valve: one (1) strut remained bent outwardly at inflow side after deployment.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.The instructions for use/training manuals were reviewed for guidance/instruction involving the valve usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The valve frame damage was confirmed based on the provided imagery.Per training manual, "insertion force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification" and "if insertion force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1-2 cm." in this case, the patient was obese, and it is possible that the sheath kinked during maneuvers performed to introduce the delivery system through sheath.Additional manipulation was likely applied to overcome the resistance caused by the kinked sheath and the difficult anatomy, and it is possible that this caused the valve frame to interact with the kinked sheath shaft during insertion, resulting in frame damage observed in the imagery provided.As such, available information suggests that procedural factors (kinked sheath, excessive device manipulation, high push force) 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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: 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: 18812889
• MDR Text Key: 336622982
• Report Number: 2015691-2024-01478
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female