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

Model Number 9750TFX26A

Device Problems Gradient Increase (1270); Structural Problem (2506); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), approximately 6 months 2 days post transfemoral valve in valve tavr procedure with a 26mm sapien 3 ultra valve in a surgical valve, the valve was reported to be possibly failing due to the leaflets being mildly thickened with hypomobility.Per tte 1 year 3 months post tavr findings showed a mean gradient of 24 mmhg.Proctor review recommended bav prior to a valve in valve (vinv).The team plans to proceed to a vinv, however, the date had not been determined.

Manufacturer Narrative

Correction to h6 based on additional information.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.Available imagery was reviewed by ew proctor and imaging team and the following was commented: all transthoracic echocardiograms from this patient are technically limited.It is very difficult to visualize the leaflets by tte on this patient.On post operative day 1, the mean gradient through the thv was 23mmhg, which is consistent with the most recent gradients 24 mmhg.The tee approximately 5 months later showed the leaflets are mildly thickened with hypomobility of the right and left cusps.The 26 mm sapien 3 valve was not the correct size valve for the pre-existing valve.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no 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 complaints for halt, leaflet motion restricted-in patient and increased gradients were confirmed from imagery review.As reported, 'approximately 6 months 2 days post transfemoral valve in valve tavr procedure with a 26mm sapien 3 ultra valve in a surgical valve, the valve was reported to be possibly failing due to the leaflets being mildly thickened with hypomobility.Per proctor review of tee images 4 months post tavr showed a mean gradient of 27 mmhg with mild to moderate stenosis, and tte at 1 year 3 months showed a mean gradient of 24 mmhg.It is recommended to performed bav prior to a valve in valve (vinv).The team plans to proceed to a vinv with no date determined as of yet.' per instructions for use (ifu), leaflet thickening and valve thrombosis are potential adverse events associated with the use of valve.Thrombosis is formation of blood clots on valve leaflet, which may resemble leaflet thickening.In this case, 4 month post implantation imagery showed mild leaflet thickening; however, there is limited information provided for the evaluation of this complaint; therefore, a definitive root cause for the reported leaflet thickening is unable to be determined at this time.Imagery confirms mild leaflet thickening.Thickening of leaflets impacts proper functionality coaptation, and results in restricted leaflet motion.As such available information suggests patient factors (thickened leaflet) may have contributed to the complaint event.It is normal to have a small gradient across a prosthetic valve after implant.If gradient is elevated, it may indicate obstructed flow across the valve.An increase in gradients can indicate that a leaflet is not functioning optimally due to thrombosis or early valve degeneration.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and results in symptoms, it may require intervention.Per imagery review performed by ew proctor, implanted valve size 26mm was not the correct size for the surgical valve without bvf (bioprosthetic valve fracture) to lower the gradient.If the pre-existing surgical valve is not fractured, thv may not be able to achieve a full expansion.Discharge tte on pod-1 shows a higher gradient (21mmhg), which is likely due to the under-expansion of the thv/ thv sizing.In this case, the gradient remained increased and in similar range (approx.4 months at 27mmhg, and approx.1 year and 3 months at 24mmhg).Presence of mildly thickened leaflet with hypomobility (reduced leaflet motion) was noted approx.4 months imagery, which can lead to increased gradients across valve.As such, available information suggests that patient factors (restricted leaflet motion due to thickened leaflets) and/or procedural factors (under-expanded valve or thv sizing) may have contributed to the reported event.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: SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• 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: 16392395
• MDR Text Key: 309733359
• Report Number: 2015691-2023-10885
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230419
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: 9750TFX26A
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR