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

Model Number 9600TFX26A

Device Problems Degraded (1153); Incomplete Coaptation (2507); Defective Device (2588)

Patient Problems Aortic Insufficiency (1715); Injury (2348); Valvular Stenosis (2697)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4) valve stenosis is listed in the instruction for use (ifu) as a potential risk associated with the use of the thv.  per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma, endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.  stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.However, it is possible patient factors such as metabolic issues contributed to the valve stenosis.A very common failure mode is tissue calcification.The mechanisms for bioprosthetic heart valve tissue calcification is not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.There are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non-functioning 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.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.A device history record review was performed and review of the work orders did not reveal any issues that may have contributed to the complaint event.In this case, the cause of the stenosis is unknown.In addition, to the mechanisms described above, patient factors, progression of a pre-existing disease processes, liver failure, renal failure including dialysis, and hyperparathyroidism may have contributed to the 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.No corrective or preventative actions are required.

Event Description

As reported through an edwards field clinical specialist, approximately 2 years and 3 months post implantation of a 26mm sapien 3 valve in the aortic position via transfemoral approach with a 26mm commander delivery system, valve stenosis was observed.The following was observed, mild perivalvular aortic insufficiency, mean gradient of 74mmhg, valve area of 0.34cm, and the prosthetic valve leaflet motion is impaired.A valve in valve was performed.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 10370226
• MDR Text Key: 202053610
• Report Number: 2015691-2020-12943
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Model Number: 9600TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR