| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00291-1 |
| Product Name/Description |
Lotus Valve System
Material Description: LOTUS TAVR 23mm, H749LTV230
Batch Number: 19634742
Material Description: LOTUS TAVR 25mm, H749LTV250
Batch Number: 19520317, 19696773,19520319 and 19696774
Material Description: LOTUS TAVR 27mm, H749LTV270
Batch Number: 19686549 and 19978598
ARTG Number: 260448 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has received higher than anticipated number of reports of early pin release prior to locking the valve in the final position. If this occurs, the valve is unable to be fully locked, which requires the valve to be re-sheathed and removed from the patient prolonging the procedure. Removal of the valve was successful in all but one case where the valve embolised and was secured in the descending aorta. All patients were successfully treated with another valve, except for one reported case where the affected valve was removed, but an aortic dissection occurred during implantation of the second valve whereby the patient subsequently died.
Please note that there are no safety concerns for patients who have previously received a Lotus Valve and the issue does not impact the performance of the implanted valve. It is only a potential issue during the implant procedure itself. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific (BSC) is advising users to immediately discontinue use of and segregate affected products. Users are further advised to immediately remove all affected products from their inventory and quarantine the affected stock in a secure location prior to their return to BSC.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG |
| Contact Information |
1800 676 133 - Boston Scientific |