MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

Patient Problems Angina (1710); Aortic Valve Stenosis (1717); Ischemia (1942); Thrombosis (2100); No Code Available (3191)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Residual mean gradient may be higher in a ¿thv-in-failing bioprosthesis¿ configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device.Patients with elevated mean gradient post procedure should be carefully followed.It is important that the manufacturer, model and size of the preexisting bioprosthetic valve be determined, so that the appropriate valve can be implanted, and a prosthesis-patient mismatch be avoided.Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the inner diameter as possible.Residual gradients after implantation may result from patient factors such as hypertrophic cardiomyopathy (hcm), sub-valvular aortic stenosis, or inadequate leaflet coaptation.It may also be indicative of sub-optimal frame expansion or patient-prosthesis mismatch.Over time, gradients can develop or worsen due to leaflets being affected by the development of calcification, or the formation of pannus/host tissue, or thrombus.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.In the post-operative period, leaflet restriction (e.G.Increased gradients, thickened leaflets) can occur with or without the development of clinical symptoms.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.In this case, the cause for the increased aortic gradients and ¿concern about the movement of one of the tavr leaflets¿ cannot be determined based on the limited information provided.It is possible that the event was due to may be due to unknown patient/procedural factors.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 by our implant patient registry through our (b)(6) affiliate, approximately 7 months post implantation of a 26mm sapien 3 valve in the aortic position inside a non-edwards 27mm surgical bioprosthesis valve, the patient presented with worsening angina symptoms.Imaging test revealed ischemia in the anterior and septal walls and the coronarography revealed severe distal left main and ostial left anterior descending coronary arteries disease.Subsequently the patient was referred for a cabg.During cardiac work-up it was found that the aortic mean gradient had increased from 13mmhg post-tavr to 26 mmhg.An echo (tee) was performed before cabg and there was concern about the movement of one of the tavi leaflets and, given the increased in the aortic gradients (in the range of moderate aortic stenosis) a decision was made for removing both the 26mm sapien 3 valve and the previous non-edwards 27mm bioprosthesis valve.A 25mm edwards surgical valve was implanted.

Manufacturer Narrative

A supplemental report is being submitted, after further clinical review this event is being updated as prosthetic cardiac valve thrombosis.The following sections of this report have been updated: b5 (describe event or problem), f10 (patient code) and h10 (narrative text).Per the instructions for use (ifu), valve thrombosis is a potential risk associated with the use of the transcatheter heart valves (thv).Thrombosis is a rare and well-recognized complication associated with the use of bioprosthetic heart valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Anticoagulation therapy must be evaluated patient by patient.The cause for valve thrombosis is thought to result from an interaction between components of blood and the prosthesis or turbulent blood flow in and around the prosthesis.Several factors can cause development of thrombosis, including: inadequate anticoagulant therapy after valve implant, atrial fibrillation, medications, cancerous tumors, systemic diseases (e.G., systemic lupus erythematosus, inflammation and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), and reduced cardiac pumping (low ejection fraction).Thrombosis has an extremely low incidence rate in bioprosthetic heart valves.Thrombosis is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Since the mechanism of thrombotic deposition on bioprosthetic heart valves is not fully understood, the cause cannot always be confirmed.In this case, per report, thrombosis was the most likely cause of leaflet restricted motion causing increased gradients.There was no allegation or indication a device malfunction contributed to this adverse event a complaint history for this type of event is 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 preventive actions are required.

Event Description

Of last communication, the patient was discharged without significant complications and stable.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10392189
• MDR Text Key: 202804739
• Report Number: 2015691-2020-13023
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: 9600TFX26
• 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