| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00306-1 |
| Product Name/Description |
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems
(indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms)
Multiple Product and Serial Numbers
ARTG Numbers: 158456, 197539 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have identified that a specific subset of Endurant/ Endurant II Bifurcated Stent Graft Systems have greater susceptibility to permeability variations associated with endoleaks identified during the initial implant procedure. At the time of implant procedure, in the event of an endoleak, this potential permeability variation in the affected subset of stent grafts may cause the physician to categorise a Type IV endoleak (which typically self-resolves over time) as an acute Type III Fabric endoleak because the leak may appear to be focal or a localised leak as opposed to a diffused leak (blush). This potential misclassification of a Type IV endoleak as an acute Type III Fabric endoleak may lead to unnecessary secondary interventions to treat the perceived acute Type III endoleak, whereas it could be a Type IV endoleak that self-resolves over time. This potential permeability variation observation is limited to a subset of 23mm and 25 mm devices. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised to identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers that are in their inventory. Medtronic is also advising that there are no actions required for patients already implanted, as the potential for endoleak misclassification due to permeability variation occurs acutely at implant. Patients who have been implanted with an Endurant /Endurant II 23mm or 25mm Bifurcated Stent Graft System affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with the standard practice.
This action has been closed out on the 11/09/2018 |
| Contact Information |
1800 668 670 - Medtronic |