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 10/23/2023

Event Type  malfunction  

Event Description

As reported by our affiliates in portugal, during the transfemoral transcatheter aortic valve replacement (tavr) procedure with a 26 mm sapien 3 ultra valve, the delivery system with crimped valve was unable to be advance through the 14 fr esheath.It was noted that the esheath had been inserted at a steep angle and the loader was able to be fully inserted into the esheath.The entire system was withdrawn as a unit without any patient injury.A second delivery system and valve were prepared and the 14 fr esheath was replaced with a 16 fr esheath.There were no issues during the second implant attempt and the valve was implanted successfully.The valve device was returned for evaluation.Evaluation of the returned device revealed two bent struts outwards at the inflow side.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2023-17544 for details of the other event.The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).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 returned to edwards lifesciences for evaluation.Visual inspection of the returned device revealed a crimped valve exposed through the sheath.There were two struts bent outwards at the inflow side.The valve was then expanded, and one strut remained bent outwards at the inflow side.The leaflets were noted to be wrinkled and dehydrated due to storage conditions (prolonged crimping) during the return handling process.Imagery was also provided for evaluation.Review of the imagery revealed calcification and tortuosity present in the patient's access vessels.Per the technical summary, the ifu, current risk mitigations including 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 valve frame damage was confirmed based on the evaluation of the returned device.The available information suggests that patient factors (calcification and tortuosity) and procedural factors (excessive manipulation) likely contributed to the event as per imagery provided, calcification and tortuosity were present in the patient's access vessels.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.A 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.Finally, 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 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: 18154302
• MDR Text Key: 328629952
• Report Number: 2015691-2023-17546
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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: 9750TFX26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• 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