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

Model Number 9600TFX23A

Device Problems Gradient Increase (1270); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Thv/tvt registry.Investigation of this event is ongoing.

Event Description

As reported by the field clinical specialist (fcs), the patient had a sapien 3 valve implanted in a freestyle valve.On the 30-day follow up visit after tavr the patient was found to have increased gradient of 30mmhg and a ¿frozen leaflet¿ (no central leak) which they thought may have been due to a thrombus not seen on the surface echo.It was decided to place the patient on anticoagulation and check again on the next follow up visit.It is unknown if the was patient symptomatic at the time.On the 6-month follow-up visit the gradient had not improved.After work-up, the patient was hospitalized 8 months after the tavr procedure for a bav.After post-dilation of the sapien valve the gradient improved to 8 mmhg.The gradient improved with bav and the patient was stable.The patient was discharged on the following day and was doing well.

Manufacturer Narrative

Additional information from the medical records provided by the facilities: patient with longstanding history of valvular heart disease.The patient underwent surgical avr in 2000.17 years later, the patient developed symptomatic aortic stenosis and required an aortic valve replacement redo.Pre-tavr gradients were 66 mmhg peak and 42 mmhg mean with valve area of less than 1 sq.Cm.Per the op note: the 23mm sapien 3 valve was implanted in a 21mm freestyle heart valve in good position with no coronary occlusion and no aortic regurgitation.However, the aortic valve mean gradient decreased only to 30 mmhg mean with a peak flow velocity of 3.7 m/sec.The 30-day follow up visit echo reported high velocity across the valve, max velocity of 370 cm/sec with an avmg 28 mmhg.A tee performed 6 weeks after tavr reported: ¿there is no insufficiency at all of the valve.There is a significant gradient across the valve with maximal velocity of 370 cm/second with a mean gradient of 28mmhg.¿ per the report conclusions: ¿aortic valve prosthetic malfunction, with reduced motion of the leaflet adjacent to the left atrium.There is definite strong suggestion of thrombus between the leaflet and the ascending aortic wall.In some views, this appears to be relatively large burden of thrombus or some other space occupying lesion.¿ the 6-month follow up visit tte reported that the velocity and gradient through the s3 valve had increased when compared with previous echocardiogram (done 3 months earlier).The velocity had increased from 3.1 to 3.7 m/sec, mean gradient increased from 21 to 27 mmhg, dimensionless index was decreased from 0.45 to 0.35, and the effective orifice area decreased from 0.86 cm2 to 0.76 cm2.The patient was initially anti-coagulated with warfarin, later with the xarelto due to fluctuating inrs.After being anticoagulated for several months, the patients symptoms (sob) did not improve and 8 month s/p tavr the patient was re-admitted for elective bav.A tee performed during this admission reported the max velocity of 3.0 m/s with a peak and mean gradient of 36/21 mmhg.¿there appears to be adequate systolic leaflet excursion.There is no evidence of thrombus or vegetation.¿ bav procedure was successfully performed, no complications during procedure or in recovery.But the valvuloplasty did not have desired effect/results on pressures within the heart.A consult with the cv hospitalist was requested on possible non-cardiac cause to the patient¿s sob.Per the cv hospitalist consultation notes, the patient showed clinical improvement of her symptomatology immediately post bav procedure, indicating that a large majority of her symptoms may have been due to the velocities, even if the numbers do not suggest this.The physician agreed with the patient¿s family that there was a sense of malaise and failure to thrive which may be concerning for other issues including occult malignancy, and the patient was recommended to follow up with the primary care physician to investigate further.The patient was discharged home in good condition.Per the instructions for use (ifu), valve thrombosis is a possible risk associated with the use of the valve.The ifu cautions that incorrect sizing of the valve may lead residual gradient (patient-prosthesis mismatch).Residual mean gradient may be higher in a ¿thv-in-failing bioprosthesis¿ configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device.Patients with elevated mean gradient post procedure should be carefully followed.It is important that the manufacturer, model and size of the preexisting bioprosthetic valve be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided.Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the inner diameter as possible.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.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, the cause of the apparent leaflet immobility 6 weeks after the tavr procedure cannot be confirmed.However, the physicians speculated that it could be a thrombus.Per report, post deployment of the s3 valve, the peak velocity was 3.7 m/s and the mean gradient had decreased from 42 mmhg to 30 mmhg.8 months later, tee showed a mean gradient of 21 mmhg and max velocity of 3.0 m/s; and as the patient was symptomatic bav was successfully performed.In this case, the cause of the s3 valve high gradients cannot be determined.However, this event could be related to patient prosthesis mismatch.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.

• 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: frances preston, rn ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 7106996
• MDR Text Key: 94476085
• Report Number: 2015691-2017-04227
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2017
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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