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

Model Number 9300TFX29

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Valvular Stenosis (2697)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

As per article "early transcatheter dysfunction after transapical mitral valve-in-valve implantation" a patient was noted to have a carpentier edwards perimount 29mm mitral valve that underwent for a valve in valve due to degeneration after an implant duration of 10 years.A sapien xt 29mm was implanted successfully, however, this new valve was found to be severely stenotic with rigid and thickened leaflets but without any macroscopic signs of active infection after six months.Both valves were explanted and c-e perimount mitral 29mm was implanted successfully.The patient was discharged.

Manufacturer Narrative

The patient had an uneventful postoperative course and was discharged on oral anticoagulation international normalized ratio (inr) 2.5¿3.5 plus aspirin 100 mg/day due to a permanent atrial fibrillation.Pre-discharge transthoracic echocardiography revealed a well-functioning mitral valve-in-valve prosthesis (i.E.Without residual regurgitation, transvalvular pressure gradient mean 6 mmhg and reduced left ventricular ejection fraction (45%).At the time of hospital admission, the patient was found at nyha chf class iii, the inr was 2.05 and she had an elevated d-dimer value, slightly increased leucocytes and reactive protein c without any clinical signs of infection.Although procalcitonin was normal, empirical intravenous antibiotics (piperacillin-tazobactam) were initiated.Subsequently, tee revealed severely reduced leaflet mobility of the mitral valve-in-valve prosthesis with thrombotic apposition.Additionally, an extensive left atrial thrombus formation was demonstrated.No bacteria or fungi could be identified in preoperatively obtained blood cultures (i.E.Before starting the antibiotic therapy) and in the operative material during 14 days of incubation.Unfortunately, all intraoperative material was sent away for microbiological analysis and therefore no histological examination was performed.The edwards sapien xt transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis.Deployment of the sapien xt valve in a previously implanted mitral ring is not indicated per the labeling.The safety and effectiveness of the sapien xt valve has not been stablished in this scenario.Valve stenosis may result in symptoms such as shortness of breath and decreased exercise tolerance, which may be accompanied by an increased gradient across the valve.Stenosis could also be due to early calcification of the leaflets, host tissue overgrowth or in rare cases, a nonfunctioning leaflet.Valve thrombosis is the formation of significant blood clots forming on the valve, which could impact functionality of the valve resulting in heart failure or thromboembolism.Valve thrombosis can be caused by inadequate anticoagulation therapy after valve implant, atrial fibrillation, certain medications, cancerous tumors, systemic diseases (systemic lupus erythematosus, inflammation and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels and brain).Despite multiple attempts, additional information regarding this event was not provided by the facility.In this case, the cause for the xt valve stenosis 6 months after being implanted within a pre-existing mitral ring cannot be determined.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 at this moment.Article citation: article as: baldizon i, espinoza a, kuntze t, girdauskas e.Early transcatheter valve dysfunction after transapical mitral valve-in-valve implantation.Interact cardiovasc thorac surg 2016;22:501¿3.

• Brand Name: EDWARDS SAPIEN XT 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: 5746973
• MDR Text Key: 48094476
• Report Number: 2015691-2016-02032
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 9300TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• 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
• Patient Age: 75 YR