MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX26

Device Problems Degraded (1153); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Aortic Insufficiency (1715); Stenosis (2263); Injury (2348)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis) is listed in the instructions for use for the tavr procedure and are known potential risks associated with the device.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, the device is not available for evaluation as it remains implanted in the patient.The cause of the valve degeneration (aortic stenosis and aortic insufficiency) was unknown.However, progression of pre-existing disease process may have been a contributing factor.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 affiliates in (b)(6), approximately six years post implant of a 26mm sapien xt valve in the aortic position, valve stenosis and aortic insufficiency ¿3/4¿ was observed.A 26mm sapien 3 valve was successfully implanted inside the stenotic sapien xt valve.At the time of the report the patient was alive.No thrombus or vegetation was observed.The cause of the aortic stenosis and aortic insufficiency was unknown.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8185574
• MDR Text Key: 131063076
• Report Number: 2015691-2018-05476
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2014
• 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: 73 YR