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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The event reported is 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 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.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The valve frame damage was unable to be confirmed as no device or applicable imagery was returned.Available information suggests patient factors (calcification, tortuosity) and procedural factors (high push force) likely contributed to the event as the patient had a very tortuous and calcified femoral artery.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Additionally, tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

Event Description

As reported from new caledonia by our edwards lifesciences affiliate, valve frame damage of the second 26mm sapien 3 ultra valve occurred during a transfemoral transcatheter aortic valve replacement procedure.During the procedure, there were difficulties to introducing the 14fr esheath+ due to the access tortuosity.The team was unable to advance the first 26mm sapien 3 ultra valve through the sheath despite the high push force.One of the valve distal struts became bent.The valve was removed.A second 26mm sapien 3 ultra valve was inserted inside the same esheath+.The valve became stuck at the beginning of the expandable portion of the sheath and was unable to advance.It was observed that one valve strut was bent.The sheath was retrieved, and it was observed that the sheath was damaged "in the middle of the blue part" with a tear measuring over 3 cm.A 23mm sapien 3 ultra kit was prepared.The third valve was able to be advanced through the new sheath and reached the annulus.However, there was a loss of pacing capture during valve deployment.The loss of pacing resulted in the valve embolizing.The valve was pulled to the thoracic aorta and was secured with a 26mm balloon.An additional 23mm sapien 3 valve was prepared and successfully implanted.The patient was stable post-procedure.

• 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: 19144896
• MDR Text Key: 340612796
• Report Number: 2015691-2024-03019
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NC
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2023
• 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