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

Model Number 9600TFX

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

Patient Problem Injury (2348)

Event Date 11/16/2020

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 sapien 3 valve per medical opinion was suspected to be thrombosis. the patient was not compliant with anti-coagulation regimen prescribed.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 by a field clinical specialist, a sapien 3 valve was implanted in the aortic position via transfemoral approach. post tavr, at discharge the mean gradient implant was 10-15mmhg and was found to have increased to 30mmhg on the 30 day follow up tte.Approximately two years post implant the patient was experiencing symptoms of heart failure with repeated admissions to the hospital.A recent tee showed a mean gradient of 50 mmhg and peak gradient 100 mmhg.They had attempted to treat the patient with coumadin, it was thought the increased gradient was due to leaflet thrombosis.The patient was prescribed anticoagulation medication however, was not compliant therefore the it was unclear if the medication had any effect.A balloon valvuloplasty was performed with a non-edwards true balloon.Post procedure the patient's peak discharge was 22mmhg with the valve functioning as intended.The patient was in stable condition post procedure.  per medical opinion, the physician could not confirm leaflet thrombosis.The leaflet motion of one of the leaflets was noticeably reduced compared to the other two.The reduced mobility leaflet seemed to open and close fine but excursion was different.The cardiologist suspected it was from thrombus formation.

• Brand Name: EDWARDS SAPIEN 3 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10993182
• MDR Text Key: 220969915
• Report Number: 2015691-2020-14978
• Device Sequence Number: 1
• Product Code: NPT
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2020

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 Model Number: 9600TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/11/2020
• 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: 71 YR