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

Model Number 9750TFX26A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 01/12/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Valve remains implanted.

Event Description

As reported by a field clinical specialist (fcs), approximately 1 year and 3 months post tavr procedure with a 26 mm sapien 3 ultra valve in the aortic position the patient had a valve in valve procedure due to stenosis and regurgitation.Another 26mm sapien 3 ultra valve was successfully implanted.Per the fcs the baseline peak/mean gradient upon deployment was pg: 24/mg: 19 mmhg.The current mean gradient is 1 mmhg.The patient was symptomatic with shortness of breath, volume overload and leg swelling.The ava indexed is 1.2cm2/m2.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The device was not returned for evaluation.As the device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.The complaints for central regurgitation and improper leaflet coaptation were confirmed based on provided medical records.A review of dhr, lot history, and complaint history did not identify any manufacturing non-conformances that would have contributed to the reported event.Additionally, no ifu/training manual inadequacies were identified.During the manufacturing process, all sapien s3 ultra valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect contributed to the event.As reported, ''approximately 1 year and 3 months post tavr procedure with a 26 mm sapien 3 ultra valve in the aortic position the patient had a valve in valve procedure due to stenosis and regurgitation''.Additionally, the ct performed on 01/05/2023 indicated that ''there is mild prolapse of the leaflet in rcc position and abnormal motion (with some restriction and possible disrupted anatomy of the leaflet close to commissure with lcc, not well visualized) of the leaflet in ncc position, which would explain the aortic insufficiency seen by echo''.It was noted that there was mild prolapse of anatomical leaflet at rcc position, which could have interfered the normal blood flow pressure required for proper valve function, leading to abnormal coaptation of the ncc leaflet.As such available information suggests patient factors (leaflet prolapsed) may have contributed to the reported leaflet coaptation.Due to improper leaflet coaptation, the normal functioning of leaflet is impacted resulting in observed central leak.As such, available information suggests that patient factors (improper leaflet coaptation) may have contributed to the central regurgitation.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.There were no ifu/training materials inadequacies or edwards defect identified.Therefore, no corrective or preventative actions nor product risk assessment (pra) is required.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information based on medical record review.The following sections of this report have been updated: corrected information: h.6 device code(s) (corrected from gradient increase, difficult to open or close and fluid leak to fluid leak).The investigation is ongoing.

Event Description

Per medical records review, a tte performed 1 year and 1 month post tavr reported that the s3u valve had trace transvalvular regurgitation, no paravalvular leak and with normal prosthetic gradient.Av mean gradient was 8 mmhg.Approximately 2 and a half months later the patient presented with shortness of breath, suspected pulmonary edema and a new cardiac murmur.A tte performed reported that the s3u valve appeared to be well seated, with a mean gradient of 12 mmhg and peak velocity 2.4 m/s, av area cont vti 3.3 cm2.There was significant valvular aortic regurgitation which is at least moderate to severe and possible severe.A tee was performed to clarify the etiology of the regurgitation, per the report: aortic regurgitation is eccentric and posteriorly directed and appeared to be severe.There appeared to be prolapse of the anatomical right coronary cusp (rcc) which is a possible mechanism for the regurgitation.The noncoronary cusp (ncc) was not well visualized which was ''concerning for complete degeneration/tear, but shadowing may be obscuring the view.No evidence of vegetation or thickening of the visualized leaflets''.A cardiac ct scan done reported: the s3u''valve is well-seated, the valve is well seated, the leaflets are not well visualized but the leaflet thickness is not increased except for mildly increased thickness at the base of the left leaflet.It appears that there is mild prolapse of the leaflet in rcc position and also abnormal motion of the ncc leaflet (with some restriction and possible disrupted anatomy of the leaflet close to commissure with lcc, not well visualized), which would explain the aortic insufficiency seen by echo.'' there is no image of perivalvular leak.Per tte done post valve-in-valve procedure there was no aortic valve regurgitation, mean gradient 5 mmhg, no stenosis.

• Brand Name: EDWARDS 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: 16315843
• MDR Text Key: 309010053
• Report Number: 2015691-2023-10665
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)230531
• 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,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• 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: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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