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

Model Number 9750TFX20A

Device Problems Fluid/Blood Leak (1250); Unintended Collision (1429); Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 12/20/2023

Event Type  Injury  

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 20mm sapien 3 ultra valve, aortic insufficiency was noted.The patient underwent a valve in valve procedure with a second 20mm sapien 3 ultra valve.

Manufacturer Narrative

Instigation is still ongoing.

Manufacturer Narrative

Investigation is still ongoing.

Event Description

It was initially reported by the field clinical specialist (fcs), that during a transfemoral tavr procedure with a 20mm sapien 3 ultra valve, aortic insufficiency was noted.The patient underwent a valve in valve procedure with a second 20mm sapien 3 ultra valve.However, per medical records received, the 20mm sapien 3 ultra valve was implanted in a surgical valve with the intent to post dilation and fracture the surgical prosthesis.This led to severe aortic regurgitation requiring a second valve.The valve in valve procedure was successfully performed.A repeat echo report was done showing no paravalvular leakage.Then the valvuloplasty system was retrieved, and the team attempted to retrieve the stent which had dislodged from the balloon due to acute angulation of the left main takeoff and the frame of the 3 prosthesis valves.The team elected to deploy the stent and place it between the 3 stent frames.The patient tolerated the procedure well.

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.Additional assessment of the failure mode is not required at this time.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.Potential root causes for central regurgitation at time of implant includes valve malposition, slow recovery of blood flow, leaflet impingement due to calcification (for native landing zone), leaflet impingement due to guidewire, over inflation/ post-dilation, and under expansion.Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients.Often moderate to high regurgitation requiring reoperation in the immediate post-operative period is due to patient and procedural related issues and is unrelated to the device.However, advances in valve design and bioprosthetic material have been made with the intention of reducing central leaks by providing more efficient hemodynamics and longer tissue durability.The complaints for deployed valve exhibits regurgitation and interventional device interacts with coronary stent were confirmed based on provided medical record.As such, available information suggests that procedural factors (post-dilation and maneuvering of non-edwards device relative to deployed valve) may have 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: 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: 18515186
• MDR Text Key: 332880322
• Report Number: 2015691-2024-00416
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201314
• UDI-Public: (01)00690103201314(17)260927
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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: 78 YR
• Patient Sex: Female