MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-20 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM 9600TFX26 manufactured by Edwards Lifesciences.
[127939656]
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. During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution. This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event. The device was not available for evaluation, as it remains implanted in the patient. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. The exact cause of the reported thrombosis nine months after s3 implantation is unknown. It is possible that patient factors may have contributed to the event. However, other potential contributing factors are unknown as limited clinical information was provided. 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. Maxime berthelot-richer, m. (2017). A case of severe late transcatheter heart valve thrombosis with successful response to anticoagulation. Cardiovascular imaging case reports, 75-77.
Patient Sequence No: 1, Text Type: N, H10
[127939657]
As reported by our thailand affiliate, approximately nine months post implantation of a 26mm sapien 3 valve in a mitral valve in ring, an echo (tee) revealed leaflet thrombosis. The patient was admitted for monitoring and medically treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04806 |
| MDR Report Key | 8090499 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-20 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2017-08-16 |
| Date Added to Maude | 2018-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FRANCES PRESTON |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492505190 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-11-20 |
| Model Number | 9600TFX26 |
| Device Expiration Date | 2019-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-20 |