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

Model Number 9600TFX23A

Device Problem Gradient Increase (1270)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular aortic stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to calcification or early thrombus formation.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of a valve leaflet malfunction.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 the valve academic research consortium (varc), prosthetic heart valve device success is described as no prosthesis- patient mismatch and mean aortic valve gradient <20 mmhg or peak velocity <3 m/s, and no moderate or severe prosthetic valve regurgitation.Valve-related dysfunction (structural valve deterioration) is described as a mean aortic valve gradient >20 mmhg, eoa <0.9-1.1 cm2 and/or dvi <0.35 m/s, and/ or moderate or severe prosthetic valve regurgitation requiring repeat procedure (tavi or savr).In the short term, abnormally high gradients may indicate a leaflet that is not functioning optimally, while in the longer term an abnormally high gradient could result from calcification of the leaflets.Abnormally low gradients may be a symptom of regurgitation.In this case, the cause of the increase in gradient across the valve cannot be determined from the information available; there is no actual report of valve thrombosis or other cause for the reported event.No information regarding the treatment was provided.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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, approximately 3 years, 3 months post successful viv mitral valve replacement the patient presented with increased gradient (12mmhg) and symptoms of heart failure.At the time of the 23mm sapien 3 valve was placed within another 23mm sapien 3 valve, within a failed surgical heart valve in the mitral position.A 23mm true balloon inflated to 17atm was used and the gradient decreased to 5mmhg.The visual waste was decreased and the physicians felt this was a hemodynamically significant improvement.The patient tolerated this procedure well and is anticipated to be discharged from the hospital tomorrow.The valve in valve in valve procedure, requiring two 23mm sapien 3 valves, was reported via the thv/tvt registry.The serial number of the valve experiencing increased gradient is unknown, both serial numbers (b)(4) and (b)(4) were implanted at the time of the implant in 2018.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 12457343
• MDR Text Key: 273085839
• Report Number: 2015691-2021-05142
• Device Sequence Number: 1
• Product Code: NPU
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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