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

Model Number 9300TFX26

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Regurgitation (2259); Stenosis (2263); Injury (2348)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

The valve was not returned to edwards for evaluation as it remains implanted in the patient.No imagery was provided.Device degeneration is a known potential risk associated with the tavr procedure and is listed in the instructions for use (ifu) as a potential adverse event.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 these adverse events.Based on the limited information provided, the root cause for the valve degeneration proximally 8 years post valve implant could not be confirmed, but may be related to the patient¿s co-morbidities not provided and/or pre-existing valvular disease process.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.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), 8 years post implant of a 26mm sapien xt valve, the valve was stenosed (27 mmhg max gradient, vmax 2,58m/sec) with severe regurgitation (peri and intra prothesis leak).A 26mm sapien 3 valve was successfully implanted inside the sapien xt valve in valve (viv).

Manufacturer Narrative

Reference (b)(4).

• Brand Name: EDWARDS SAPIEN XT 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: 10254521
• MDR Text Key: 199986232
• Report Number: 2015691-2020-12460
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9300TFX26
• 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: 84 YR