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

Model Number 9000TFX23A

Device Problems Degraded (1153); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported, 6 years and 8 months post implant in the aortic position, a 23mm sapien valve ¿failed¿.A new 23mm sapien 3 ultra valve was implanted in the sapien valve during a transfemoral valve in valve (viv) procedure.Information regarding the mode of failure or patient symptoms due to the failing valve was not provided.Post viv status of the patient is not known at the time of the report.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.The valve was not returned to edwards for evaluation as it remains implanted in the patient.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 particular case, despite multiple investigational attempts, it was not possible to obtain additional details regarding the reported sapien valve failure.To date, information regarding the patient (medical records and procedure op notes) have not been received.Based on the limited information provided, the root cause for the valve degeneration 6 years and 8 months post implant could not be confirmed, but may be related to patient factors not provided.A supplemental report will be submitted in accordance with 21 cfr 803.56 when and if additional information becomes available.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.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 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: 10280222
• MDR Text Key: 199106654
• Report Number: 2015691-2020-12525
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P110021
• 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,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2015
• Device Model Number: 9000TFX23A
• 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: 83 YR