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

Model Number 9750TFX23

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/29/2021

Event Type  Injury  

Event Description

Thv/tvt registry alternative summary reporting adverse event submission for events received by edwards during quarter 1 2022 for aortic serious injury events for the sapien 3 ultra valve.Thv/tvt registry alternative summary reporting for serious injury device thrombosis event associated with the sapien 3 ultra transcatheter heart valve, in the aortic position, for quarter 1 2022.This report is for device thrombosis serious injury event for sapien 3 ultra transcatheter heart valve.The age for this event is 74 years.The gender is as follows: female.

Manufacturer Narrative

Exemption number e2016006.This report provides data from thv/tvt registry data exemption number e2016006 and summarizes 1 of aortic serious injury device thrombosis for the sapien 3 ultra transcatheter heart valve in aortic position.The 'time to event' (tte, in days) for this event was 408.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (b)(4).Per the instructions for use (ifu), valve thrombosis is a potential risk associated with the use of the transcatheter heart valve (thv).Valve 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.In this case, specific clinical details were not available, and it is not possible to determine potential contributing factors.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.

Manufacturer Narrative

Correction to the exemption number field per fda request on 07/07/2022.

• Brand Name: EDWARDS SAPIEN 3 ULTRA VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 14881130
• MDR Text Key: 295115261
• Report Number: 2015691-2022-06476
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: 2016006
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 07/07/2022
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Female