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

Model Number 9600TFX26

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Endocarditis (1834); Thrombosis (2100); Heart Failure (2206); Stenosis (2263); Respiratory Failure (2484)

Event Date 06/17/2020

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.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause for the valve thrombosis could not be confirmed.However, patient factors and/or the mechanisms described above are likely contributing factors for the 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.

Event Description

As reported by our affiliates in (b)(6), approximately 6 years post implant of a non-edwards bioprosthesis in the aortic position, a 26mm sapien 3 valve was implanted within the valve.On routine echocardiography six weeks post-implant, severe stenosis with pmax > 80 mmhg was noticed.Tavi valve thrombosis was suspected and confirmed by ct.The patient was switched to vitamin k antagonist.Several days later, the patient was admitted for imminent respiratory failure caused by acute heart failure due to progressive tavi stenosis.Upon fibrinolysis administration, thrombus resolved partially and gradient was substantially lower.Patient was discharged, but was readmitted several days later with similar complaints.Re-operation was performed and the sapien 3 valve and the bioprosthesis were explanted.A new bioprosthesis was implanted.At the time of the report, the patient was recovering.Microbiology of the tavi valve showed extensive aspergillosis and thrombus.Aspergillus antigen was also detected in blood.Pet-ct showed no substrate for aspergillosis, making it more likely that this complication was related to the device itself and/or the recent implantation.

Manufacturer Narrative

Code added to section f10.Per the instructions for use (ifu), infection including septicemia and endocarditis, is a potential adverse event associated with aortic valve replacement.Endocarditis is an infection of a native or prosthetic valve, is treated with antibiotics, and may require valve replacement if antibiotic therapy is not effective.Causes of prosthetic valve endocarditis are well documented in the literature and are typically classified as early (<60 days) or late (>60 days).Early prosthetic valve endocarditis is usually caused by perioperative bacterial contamination of the valve.Edwards lifesciences produces and provides sterile tissue bioprostheses to its customers by following carefully designed robust sterilization processes.These manufacturing processes have been validated and demonstrated to consistently provide a significant safety factor from which microorganisms could not survive.Microbiology and process monitoring is routinely reviewed within quality systems to maintain sterility control.Validated testing has demonstrated that microorganisms could not survive edwards¿ multi-stage processing with enhanced sterilant or heated glutaraldehyde terminal sterilant solution.These multiple, redundant manufacturing controls ensure the sterility of edwards¿ valves as provided to customers.Therefore the probability of endocarditis related to edwards¿ bioprostheses is remote.In this case, there was no allegation or indication of a device malfunction.The source of the aspergillosis infection was unknown.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 at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa: 20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10409518
• MDR Text Key: 203323307
• Report Number: 2015691-2020-13139
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR