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

Model Number 9755RSL29A

Device Problem Material Deformation (2976)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

As reported by field clinical specialist, during a transfemoral aortic valve replacement procedure with a 29mm sapien ultra resilia valve, the esheath+ was damaged when the valve was inserted, and a new sheath was needed.There was a lot of push force noted when the valve was inserted.Once the valve came out of sheath, it was noted that there was a bent strut.The physician attempted to pull the valve back in the sheath but was unable to.They decided to deploy valve in the aortic position.The strut opened up and there was no harm to the patient.

Manufacturer Narrative

The investigation for this report is ongoing.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-00034.The valve remains implanted and was, therefore, not returned for evaluation.Imagery was provided and reviewed.Calcification and tortuosity were observed to be present in the patient's right access vessel.One (1) bent strut was observed on the inflow side of the valve.The bent strut was corrected after valve deployment.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.A review of edwards lifesciences risk management documentation was performed for this case.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.An edwards technical summary applies to this event and 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 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.Review of the ifu and training materials is detailed in the technical summary and continues to provide adequate instructions on device use, risks, and precautions.In addition, review of manufacturing mitigations is captured in the technical summary, which are still in place.With no unique issues or concerns raised with this complaint, this event will be included in ongoing monitoring and trending with no pra or capa required at this time.The valve frame damage was confirmed based on the provided imagery.Available information suggests patient factors (calcification, tortuosity) and/or procedural factors (excessive manipulation/high push force) likely contributed to the event as calcification and tortuosity was observed and one (1) bent strut was observed on the inflow side.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.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.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.

• 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: 18293897
• MDR Text Key: 330068800
• Report Number: 2015691-2023-18234
• 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,Followup
• Report Date: 01/23/2024

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: 9755RSL29A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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
• Patient Sex: Female
• Patient Weight: 79 KG