MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23 MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23A

Device Problem Gradient Increase (1270)

Patient Problems Infarction, Cerebral (1771); Death (1802); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109)

Event Date 02/13/2020

Event Type  Death  

Manufacturer Narrative

The edwards sapien 3 transcatheter heart valve and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve, who are judged by a heart team, including a cardiac surgeon, to be at low or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 1% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator). the use of a sapien 3 valve in a native mitral position is not indicated per the labeling; therefore, the device instructions for use and procedural training manual do not provide direction for the use of the device in this application.  as there are no specific ifu or training materials related to sapien 3 with native mitral procedures, the available training materials were reviewed only for information potentially relevant to the device use.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 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 intervalvular 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.A very common failure mode is tissue calcification.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, as limited information was provided, there are no known risk factors that could have contributed to the event (end-stage renal insufficiency, disorder of calcium metabolism).The root cause of this event could not be determined.In this case, the cause of the increase in gradient across the valve and subsequent brain ischemia resulting in the patient death cannot be determined from the information available.  further detailed information was requested but not forthcoming. 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 by a field clinical specialist, a 23 mm sapien 3 valve was implanted surgically in the mitral position and on pod 4 the valve was post dilated due to a high gradient.Three years post implant the patient became symptomatic and there was an increased gradient of 27 mmhg. anti-coagulation was prescribed, and the gradient remained unchanged. a valve in valve with a 20mm sapien 3 via a trans-septal approach was performed.The team elected to use the sentinel embolic protection system.The device was deployed without incident.Post op same day a ct was performed revealing a small bleed, and brain ischemia.The patient expired the next day due to ischemic stroke.

Manufacturer Narrative

Reference capa-(b)(4).

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 23 MM
• Type of Device: PROSTHESIS, MITRAL VALVE, 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 ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 9793696
• MDR Text Key: 182205825
• Report Number: 2015691-2020-10805
• 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
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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): Death
• Patient Age: 7 YR
• Patient Weight: 24