| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00447-1 |
| Product Name/Description |
Lotus Valve System (a transcatheter aortic valve implantation (TAVI) system)
Lotus TAVR 23mm
Material Number: H749LTV230
Catalogue Number: LTV23
All batches affected
Lotus TAVR 25mm
Material Number: H749LTV250
Catalogue Number: LTV25
All batches affected
Lotus TAVR 27mm
Material Number: H749LTV270
Catalogue Number: LTV27
All batches affected
ARTG Number: 260448 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific’s (BSC) review of the post-market data has identified an increase in the number of complaints related to ‘Catheter Release Pin Mandrel Break’. The failure can occur during sheathing as part of device preparation or re-sheathing during the procedure, if repositioning is required. The release mandrel break is most commonly identified during the valve releasing phase of the procedure. In the event of a broken release mandrel, the physician will re-sheath the valve and replace the device.
In addition to the 24 complaints reported during Nov 2014 – Jan 2016, there were 8 complaints reported in February 2016 related to release mandrel. There has been one complaint event reported in February 2016 which resulted in a patient death. BSC’s investigation concluded that incorrect preparation of a device may contribute to increased opportunity for the release mandrel to break. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Boston Scientific (BSC) is initiating this action to:
1- Provide additional clarification on the instructions for preparing the Lotus Valve System prior to the procedure; and
2- Ensure all certified physicians have received all training necessary for independent implantation of the device, i.e., without the support of a BSC Field Clinical Specialist (FCS).
Boston Scientific is advising users that the relevant training manuals have been updated to avoid crimping the mid-section of the valve during sheathing. Boston Scientific Field Clinical Specialist will re-train all cath-lab staff in the revised procedures. Users in "Non Independent" sites are reminded to ensure all procedures are completed with the support of a Boston Scientific Field Clinical Specialist until the site has been designated to be "Independent" by Boston Scientific. This action has been closed-out on 30/01/2017. |
| Contact Information |
02 8063 8146 - Boston Scientific |