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

Model Number 9300TFX29

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Mitral Valve Stenosis (1965); Insufficient Information (4580)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Valve remains implanted.

Event Description

As reported by our affiliates in (b)(6) , 10 years and 1 month post implant of a 29mm sapien xt in a surgical valve in the mitral position, the valves were explanted and a 27mm surgical valve was implanted.The reason for the explant is unknown.

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our affiliates in italy, 10 years and 1 month post implant of a 29mm sapien xt in a surgical valve in the mitral position, the valves were explanted due to severe stenosis and a 27mm surgical valve was implanted.The patient outcome was good.

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.No imagery was provided for review.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.Devices implanted 5 years or greater with reported calcification, dehiscence, leaflet tears, thickened leaflet, pannus, or structural valve deterioration (stenosis, regurgitation) do not require an engineering evaluation.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 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, complaint was unable to be confirmed due to device unavailability/imagery unavailability.Based on the limited information provided, the root cause for the valve degeneration approximately 10 years post valve implant could not be determined, but may be related to the patient's co-morbidities and/or progression of the 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.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12086584
• MDR Text Key: 259250800
• Report Number: 2015691-2021-03821
• Device Sequence Number: 1
• Product Code: NPU
• 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,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2012
• Device Model Number: 9300TFX29
• Device Lot Number: 2820860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR