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

Model Number 9600TFX29A

Device Problem Incomplete Coaptation (2507)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.During the procedure there are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or nonfunctioning leaflet.Based on historical review of complaints, these events are typically a result of too ventricular deployment of the valve in combination with native leaflet overhang.Other potential contributing factors include: leaflet impingement in a highly calcified native valve, impingement of a leaflet due to the guide wire, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets.In many instances this can be overcome with trouble shooting, which includes blood pressure recovery or support.Occasionally there are cases where the root cause of the non-functioning leaflet cannot be determined.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.It should be noted that the thv was deployed in a 35mm cook-z stent deployed in the right atrial (ra)/inferior vena cava (ivc) junction.The edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.It is also indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.In addition, it is indicated for use in the management of patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic valve in the pulmonic position with greater than or equal to moderate regurgitation and/or a mean rvot gradient of greater than 35 mmhg.In this case, per the authors, obstruction of retrograde flow from the ra into the ivc by the presence of a prominent eustachian ridge resulted in eccentric flow of the tr jet directed away from the ivc, thereby restricting leaflet motion of the caval valve implant.Additional information was not provided by the authors.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.No corrective or preventative actions are required.The date of the event is unknown.For this reason, the date the article was received by the publisher was used as the occurrence date.Article reference: qintar, mohammed, et al.'non-coaptation of an implanted caval valve leaflets for severe tricuspid regurgitation: rethinking the concept of 'eustachian ridge?'.'catheterization and cardiovascular interventions (2021).

Event Description

As reported in the article, 'non-coaptation of an implanted caval valve leaflets for severe tricuspid regurgitation: rethinking the concept of eustachian ridge?', a patient with recurring heart failure admissions underwent a transcatheter caval valve implantation (cavi) procedure with a 29mm sapien valve in a 35mm cook-z stent deployed in the right atrial (ra)/inferior vena cava (ivc) junction.The valve was implanted superior to the most superior hepatic vein resulting in acute reduction in ivc regurgitation.Intra-procedurally, there was decreased leaflet motion on the new valve that completely resolved with fluid administration.However, on follow up in clinic after 4 weeks, the patient's ascites and lower extremity edema did not improve and thus a repeat gated cta with cavi protocol was done.Cta showed that the transcatheter heart valve leaflets were not fully coapting, with the posterior leaflet demonstrating the most malcoaptation and there was severe residual regurgitation to the ivc and hepatic veins.Further review of the 4d ct demonstrated the tricuspid regurgitation (tr) jet was directed away from the ivc by a prominent eustachian ridge which was buttressed by the z-stent.Normally, this tr jet would aid in closing the sapien leaflets in systole; however, in this case obstruction of retrograde flow from the ra into the ivc by the presence of a prominent eustachian ridge resulted in eccentric flow of the tr jet directed away from the ivc, thereby restricting leaflet motion of the caval valve implant.Additional information was not provided by the authors.

• Brand Name: EDWARDS SAPIEN 3 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; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11449449
• MDR Text Key: 242792362
• Report Number: 2015691-2021-01770
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/10/2021

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: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 45 YR