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

Model Number 9755RSL26A

Device Problem Material Deformation (2976)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

As reported by a field clinical specialist during a transfemoral aortic valve replacement with a 26mm sapien ultra resilia valve, when advancing the commander delivery system and valve into the sheath, resistance was felt almost immediately.The delivery system was in the partially expandable portion of the sheath.The physician, knowing the push force required can be significant, continued to push but did move the camera down to the femoral head to visualize the valve moving through the sheath.It was at this point the team noticed a tine from the leading portion of the crimped valve was extended laterally, acting almost like a ''barb''.The delivery system and the sheath were removed.There was a hole distal to the white wrapping of the sheath.A new sheath and delivery system were prepared, loaded over the wire, and the case was completed without further incident.

Manufacturer Narrative

The investigation for this report is ongoing.

Manufacturer Narrative

The events reported 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.The previous investigation documents the difficulty advancing the delivery system through the sheath, resulting in difficulty or the inability to introduce delivery system/loader and advance through sheath, prolonging procedure, which did occur during this event.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.The valve was returned crimped on the 26mm commander delivery system distal crimp balloon, with the valve partially inserted through full loader assembly, and 14f esheath+ returned separately.The returned device was visually examined for any abnormalities and one bent strut on the inflow side was observed, but corrected after expansion, the frame was slightly canted, and the leaflets were wrinkled and dehydrated, likely due to storage conditions during the return handling process.Due to the nature of the complaint, no applicable functional or dimensional testing was performed.The complaint was confirmed through visual examination.It has been established through extensive complaint investigations, that events reporting resistance during delivery system insertion/advancement through the sheath and potential valve frame damage using the sapien 3 ultra/sapien 3ultra resilia valve configuration have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have 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.Therefore, it is likely that these patient/procedural factors may have caused or contributed to the difficulty advancing the delivery system through the sheath and valve frame and/or sheath damage.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.In this case, the frame damage to the valve was confirmed based on evaluation of the returned device.Available information suggests patient factors (tortuosity) and/or procedural factors (excessive manipulation) likely contributed to the event as mild tortuosity in the patient's access vessel and significant push force was reported.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA 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: 18279010
• MDR Text Key: 330113006
• Report Number: 2015691-2023-18141
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2024

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: 9755RSL26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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 Sex: Male