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

Model Number 9600TFX23A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown.For this reason, the date that the manuscript was received by the publisher ((b)(6) 2020) was used as the occurrence date.Per the instructions for use (ifu), valve thrombosis is a potential risk associated with the use of the transcatheter heart valves (thv).Thrombosis is a rare and well-recognized complication associated with the use of bioprosthetic heart valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Anticoagulation therapy must be evaluated patient by patient.The cause for valve thrombosis is thought to result from an interaction between components of blood and the prosthesis or turbulent blood flow in and around the prosthesis.Several factors can cause development of thrombosis, including: inadequate anticoagulant therapy after valve implant, atrial fibrillation, medications, cancerous tumors, systemic diseases (e.G., systemic lupus erythematosus, inflammation and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), and reduced cardiac pumping (low ejection fraction).Thrombosis has an extremely low incidence rate in bioprosthetic heart valves.Thrombosis is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Since the mechanism of thrombotic deposition on bioprosthetic heart valves is not fully understood, the cause cannot always be confirmed.The edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the thv replacement therapy.It is also indicated for patients with symptomatic heart disease due to failing of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.Deployment of a sapien 3 valve in the native mitral annulus is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) does not instruct the operator how to position the sapien 3 valve in this scenario.  in this case, the cause of the prosthetic cardiac valve thrombosis cannot be confirmed, however, it is possible that patient factors ( history of: ischemic cardiomyopathy with reduced ejection fraction, esrd  on intermittent hemodialysis).There was no allegation or indication a device malfunction contributed to this adverse event.  a complaint history for this type of event is 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 preventive actions are required.Reference: alarfaj, mohammad, tushina jain, and joseph krepp.'transcatheter mitral valve thrombosis: a case report and literature review.' catheterization and cardiovascular interventions (2020).

Event Description

It was reported through a literature article, 'transcatheter mitral valve thrombosis - a case report and literature review', a patient underwent a trans-septal mitral valve in mitral annular calcification (mac) replacement with a 26 mm edwards sapien s3 valve.The tee at the end of the procedure showed minimal paravalvular leak.The deployed valve was re-dilated and repeated, the tee then showed minimal paravalvular leak.At the time of discharge, postoperative day 3, the patient was discharged on dual antiplatelet therapy (dapt), aspirin and clopidogrel, for thromboprophylaxis.The patient subsequently presented to the clinic for a 30-day follow-up and was found to be dyspneic, with orthopnea and signs of volume overload on examination.The tte showed thickened leaflets with increased mean transmitral gradient of 15 from 3 mmhg postoperatively.A subsequent tee showed a well-seated thv bioprosthesis in the mitral position with severe valvular stenosis.The neoanterior leaflet was immobile with severe subvalvular thickening, and the neoseptal/lateral leaflets were thickened with good leaflet mobility.These findings were consistent with tmv thrombosis.The patient was started on a heparin drip with bridge to warfarin with inr goal of 2.5¿3.5.The symptoms improved, and the patient was discharged on indefinite warfarin therapy.A repeat echocardiogram was done after 2 months of warfarin therapy, showed improved bioprosthesis function with mean transmitral gradient of 8 mmhg.

• Brand Name: 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10988568
• MDR Text Key: 220903857
• Report Number: 2015691-2020-14952
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• 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): Hospitalization; Other
• Patient Age: 72 YR