MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC 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 02/27/2024

Event Type  malfunction  

Event Description

As reported by the field clinical specialist, during a transfemoral aortic valve procedure, when the physician was advancing the first valve through the sheath, he encountered difficulty shortly after inserting the 26mm sapien ultra valve into the sheath.After a few hard pushes, he panned the x-ray down to the leg, the valve appeared to be stuck, and a strut was bent out.The physician attempted to remove the valve, but it became stuck and would not move in either direction.The field clinical specialist prepared a second sheath and delivery system.The physician removed the first sheath and stuck valve and delivery system as one unit, while maintaining wire position in the vessel.Per imagery provided by the field clinical specialist, bent strut was noted on the valve, along with a sheath liner tear.A new 14f esheath+ was inserted.A new valve and delivery were prepared and crimped.The second valve and delivery system passed through the sheath without any difficulties.The valve was deployed successfully and the delivery system was removed.Upon removing the esheath+, an angiogram revealed no trauma or injury to the iliac artery.

Manufacturer Narrative

The investigation for this report is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted, following completion of the engineering evaluation.H6: component, type of investigation, investigation findings, investigation conclusions, and h11 have been corrected.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 including design and manufacturing controls, 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.Imagery of the patient's anatomy was provided.Calcification and tortuosity were present in the patient's access vessel.The crimped valve was exposed through the sheath liner, post-procedure.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of suboptimal 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.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.Additionally, 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.The technical summary that applies to this complaint event establishes, through extensive complaint investigations, that events reporting resistance during delivery system insertion/advancement through the sheath and potential valve frame damage using the s3u/s3ur valve configuration have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to vessel tortuosity, calcification, undersized vessels, and/or steep insertion angle.In addition, valve frame and/or sheath damage can be a result of increased push force and any excessive device manipulation or sheath-valve interaction.In this case, frame damage to the valve was unable to be confirmed based on imagery provided for evaluation.The available information suggests patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, high push force) likely contributed to the reported event.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: 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: 18954581
• MDR Text Key: 338615946
• Report Number: 2015691-2024-02180
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260807
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 02/27/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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
• Patient Age: 89 YR
• Patient Sex: Female