| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01230-1 |
| Product Name/Description |
3f Enable Aortic Bioprosthesis - Model 6000
Supplied in Australia under either Special Access Scheme, as an Authorised Prescriber or under a Clinical Trial |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
As of 31 October 2014 Medtronic has received 17 reported events relating to valve migration (valve migration is defined as a partial or complete displacement or tilting of the valve from its original implant location.), representing an occurrence rate of less than 0.55% based on the number of devices distributed. While many of these events occurred during or immediately post-implant with no patient harm reported, in some cases, valve migration has required additional surgical intervention, which in three instances contributed to eventual patient death. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is recommending that two guiding sutures should be utilised during implantation of the valve instead of one guiding suture as noted in the current version of the IFU. The IFU will be updated accordingly; in the meantime, surgeons should reference the updated instructions provided in letter and associated training materials provided when using the 3f Enable Aortic Bioprosthesis.
Medtronic is also recommending that doctors continue to follow standard practice of performing an echocardiogram on all patients who receive a 3f Enable Aortic Bioprosthesis prior to discharge, as well as performing routine patient follow-up including physical exam. No additional actions are recommended at this time. For more information please see http://www.tga.gov.au/alert/3f-enable-aortic-bioprosthesis-model-6000 This action has been closed-out on 18/03/2016. |
| Contact Information |
1800 886 670 - Medtronic Australasia Pty Limited |