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

Model Number 9300TFX23A

Device Problem Degraded (1153)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection; therefore no dhr is required.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.  svd 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.  svd may be mild and not require any intervention or it may be moderate to severe.It can cause the heart to work harder to eject blood from the ventricle.  depending on the severity it could be an indication for valve replacement or medical intervention.  tissue calcification is a very common failure mode.  the mechanisms for bioprosthetic heart valve tissue calcification are not yet 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, there was no allegation or indication a device malfunction contributed to this adverse event.Based on the information provided, the root cause for event was likely due to patient related factors, (renal insufficiency, coronary artery disease, multiple previous valve replacements) and the progression of the patient underlying valvular disease pathology.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 at this time.

Event Description

It was reported by the implant patient registry that a patient with a 23mm sapien xt transcatheter valve, implanted in the aortic position for 6 years and 3 months underwent a valve in valve procedure due to to stenosis and regurgitation.A 23mm sapien 3 ultra was implanted. the patient left the procedure area alert and oriented and with stable vitals.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: rene dorne ; 1 edwards way; linc 4-1; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11175614
• MDR Text Key: 227004624
• Report Number: 2015691-2021-00168
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2015
• Device Model Number: 9300TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Date Device Manufactured: 06/09/2014
• 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: 79 YR