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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 11/08/2023

Event Type  Injury  

Event Description

As reported by an edwards canada affiliate, during a right transfemoral tavr procedure with a 26mm sapien 3 ultra valve, resistance was felt while attempting to advance the commander delivery system and valve through the iliac, so it was attempted to retract on the delivery system to change the angle of approach.However, the commander delivery system balloon started to align on the valve and resistance was felt on the system, so retraction of the system was stopped.The esheath appeared to have split on fluoro, and it was also observed that the distal end of the valve and the proximal end of the pusher were outside the esheath.The commander delivery and valve were removed as one unit with the esheath with difficulties due to the esheath split.The patient received 3 iliac stents to repair the vascular damage from the removal of the system.The patient was transferred to icu, and the procedure was aborted.During the icu stay, the patient stenosed iliac stents within hours of the stents being placed, and was sent for an emergency fem-fem bypass.The patient is currently recovering in stable condition in icu.The perceived root cause of the event was the patient tortuous and calcified vascular anatomy requiring the system to be torqued/heavily manipulated during the procedure.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.The device was returned for evaluation, and the following was observed: two (2) struts bent outwards at the outflow side.The crimped valve appeared moved towards the working length of the inflation balloon.After valve expansion, the frame remained distorted.The leaflets were wrinkled and dehydrated due to storage condition (prolonged crimping) during the return handling process.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.Images of the device was provided, and the following was observed: crimped valve appears punctured through sheath liner in procedural imagery.The patient's access vessel appears to have tortuous anatomy.The crimped valve was exposed through the esheath post procedure in post procedure imagery.In this case, the frame damage was confirmed based on evaluation of the returned device.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, withdrawal of crimped valve) may have contributed to the complaint 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: 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: 18378667
• MDR Text Key: 331180681
• Report Number: 2015691-2023-18681
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male