| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01015-1 |
| Product Name/Description |
Medtronic EnVeo R Delivery Catheter System (DCS)
(Supplied as part of the Evolut R System used for the Transcatheter Valve Therapy (TVT))
Models: ENVEOR-L, ENVEOR-L-C
Supplied under Clinical Trial Notification and Special Access Schemes |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
This action has been undertaken to inform users with important information regarding the potential for vascular trauma with the use of the Medtronic EnVeo R DCS. While the reports of vascular trauma received by Medtronic have been infrequent - 39 events per 24,012 sales, they have included 19 deaths. Medtronic’s observed rate for vascular trauma is lower than the TVT registry reports in the Journal of the American College of Cardiology (Holmes, et al), which highlighted annular dissection and aortic disruption rates of 0.2% and 0.4% respectively. (While this data is not provided for the purpose of direct comparison of the incidence of vascular trauma with the use of the EnVeo R DCS due to differences in the event definitions and data collection methods, this data does provide relevant context for the observed incident rate).
The TGA is continuing its review of the issue together with Medtronic and further communication on this matter may be provided at a later stage if needed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic’s investigation identified multiple recommendations to reduce the rate of vascular trauma events which includes Physicians to consider complex anatomical configurations which could increase the risk of vascular trauma and death. Also, Physicians are advised during advancement of the delivery system, to magnify images sufficiently to enable visualisation of the capsule tip relative to the patient’s vasculature. If the delivery system tip is observed to bend in a different direction relative to the delivery system capsule, do not force passage. If significant resistance is encountered during advancement of the delivery system, do not force passage.
Use increased fluoroscopic magnification to assess the vasculature. More information about how to undertake patient selection and ways to progress the procedure in difficulty cases are provided in the letter to users. The Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with this action. This action has been closed-out on 16/05/2017. |
| Contact Information |
02 9857 9050 - Medtronic |