MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23A

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834); Mitral Insufficiency (1963); Mitral Regurgitation (1964)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

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.  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 are 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.In this case, the cause of the stenosis is unknown, however may be due to the patients pre-existing valvular disease process, and/or the mechanisms described above.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 (b)(6) clinical trail, approximately 1 year and 7 months post implantation of a 23mm sapien 3 valve in the aortic position, the patient underwent a graft replacement of the aortic valve with a root replacement explanting the sapien valve and replacing it with a non-edwards surgical valve.Upon review of medical records, the patient was in for a double valve replacement (aortic/mitral) with worsening mitral regurgitation and worsening aortic insufficiency.The patient was diagnosed with endocarditis that caused dysfunction of the native mitral valve.There was no information that there was any vegetation on the aortic valve.An echo performed 1 year, and 4 months revealed a peak gradient of 61mmhg across the aortic valve (peak velocity equals 3.9 m/sec).In addition, the echo demonstrated moderate to severe mitral valve leaflet thickening with no mitral stenosis.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8710208
• MDR Text Key: 148386428
• Report Number: 2015691-2019-02211
• 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: 05/24/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2019
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR