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

Model Number 9750TFX23

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

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.Potential patient risk factors such as atrial fibrillation, systemic disease (e.G., systemic lupus erythematosus, inflammation and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), the valvular disease itself, and reduced cardiac ejection fraction can contribute to increased risk of thrombus/thrombosis.Sub-optimal anticoagulation during the procedure and underlying patient conditions can also result in increased thrombogenicity.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous preparation, aspiration, and flushing of the devices to prevent and/or remove clot(s).Short-term anticoagulation therapy may also be necessary after valve repair, anticoagulation is prescribed per institutional guidelines.Intra-procedural intra-cardiac thrombus and post-procedure or late valve thrombosis are complex processes triggered by the interaction between the host and the device which are highly variable among patients.It is the natural tendency of the body to form a clot on foreign objects in the vascular space and a definitive root cause cannot always be confirmed.The device training manuals instruct the operator to consider all procedural and anatomical factors.Physicians are extensively trained by edwards before they are qualified to use the device system.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.Operators are also instructed to use fluoroscopy in conjunction with echocardiography for optimal visualization during positioning and deployment and cautions include the maintenance of the patient-s anticoagulation status (act at >250 seconds) during the procedure.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive due to the limited information provided; however, the event could be related to the mechanisms described above.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Remains implanted.

Event Description

Per the report received from italy via clinical study, it was a case of a 23mm sapien 3 ultra valve in the aortic position by transfemoral approach.Approximately two months after tavi procedure, the patient presented with valve thrombosis leading to heart failure with an av mean pg of 61 mmhg.As a consequence, a surgical re-intervention was performed.After surgical intervention, the patient presented with multiorgan failure and expired.

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16438407
• MDR Text Key: 310182040
• Report Number: 2015691-2023-11066
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: 9750TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 66 KG