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

Model Number 9600TFX29

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

Patient Problems Thrombosis (2100); Aortic Dissection (2491)

Event Date 11/15/2020

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.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.  per the instructions for use (ifu) cardiovascular injury, such as perforation or dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.  ascending aortic dissection may occur when multiple attempts are made to cross the stenotic native valve, and/or when excessive force is used.  physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).The thv training manuals provide guidance to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torqueing of the flex catheter may be helpful in solving the problem.  in this case, there was no allegation or indication a device malfunction contributed to this adverse event.  the exact cause of the reported event was unable to be determined, but may have been due to patient and/or procedural factors not provided.  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 an edwards lifesciences affiliate in (b)(6), six months post implant of a 29 mm sapien 3 valve in the aortic position via transfemoral approach the patient was admitted with a severe aortic dissection.The sapien 3 valve was explanted and replaced with a surgical valve.Upon inspection of the sapien 3 valve two leaflets were observed to have severe thrombosis.The patient was transferred to the icu and is recovering in stable condition.Per medical opinion, there were no signs of an aortic dissection six months prior during valve deployment.The cause of the reported events are unknown.

Manufacturer Narrative

Additional information: occurrence date b4: (b)(6) 2020.Explant date d7: (b)(6) 2020.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11045933
• MDR Text Key: 222645353
• Report Number: 2015691-2020-15145
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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 Expiration Date: 12/11/2021
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85