MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER; AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23A

Device Problems Degraded (1153); Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/30/2022

Event Type  Injury  

Event Description

As reported by an edwards field clinical specialist, approximately 6 years and 6 months post implant of a 23mm sapien 3 valve in the aortic position, the valve was failing.The failure mode was reported to be stenosis.The patient presented with incremental gradient increase and presyncope.Echo showed severe prosthetic stenosis and at least moderate aortic insufficiency (ai).No actions have been taken at this time.The valve in valve procedure has been scheduled.The valve remains implanted in the patient at this time.

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.

Manufacturer Narrative

A supplemental mdr is being submitted based on review of medical records.Upon review of medical records, an echo (tte) performed at 3 years and 3 months post implant of a sapien 3 valve in the aortic position revealed a bioprosthetic aortic valve in place with trivial aortic valve prosthetic regurgitation, there was no mass or thrombus, aortic valve mean gradient of 8mmhg with an aortic valve area (ava) of 1.53.The patient presented with pre-syncope.Echo performed at 6 years and 2 months showed severe prosthetic stenosis with an increased gradient 40mmhg, moderate prosthetic aortic insufficiency and ava 0.76.Lv ef 58%.

Manufacturer Narrative

The sapien 3 valve was not returned to edwards as it remains implanted in the patient.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.The commander delivery system with s3 ifu was reviewed for instructions and guidance.Potential adverse events include valve stenosis, structural valve deterioration and device degeneration.No ifu or training deficiencies were identified.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.The complaint for degeneration/deterioration post implantation was confirmed based on medical record.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% functionally tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported, 'approximately 6 years and 6 months post implant of a 23mm sapien 3 valve in the aortic position, the valve was failing.The failure mode was reported to be stenosis.The patient presented with incremental gradient increase and presyncope.Echo showed severe prosthetic stenosis and at least moderate aortic insufficiency (ai).' per the instructions for use (ifu), 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), and device degeneration are known potential risks associated with the device.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.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, patient factors may have contributed to the event.The patient had a prior history of calcific aortic stenosis and a heavily calcified aortic root complex.It is possible that the pre-existing valvular disease played a part in promoting re-stenosis/svd.However, due to insufficient information, a conclusive root cause was unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

Event Description

Updated information revealed that the patient received a 23mm sapien 3 ultra valve successfully implanted within the sapien 3 valve.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16157360
• MDR Text Key: 307280300
• Report Number: 2015691-2023-10149
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)170303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2017
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/12/2023; 02/27/2023
• Supplement Dates FDA Received: 01/25/2023; 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female