| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01188-1 |
| Product Name/Description |
Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter)
All sizes
ARTG Number: 214148 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Vascular (AV) has recently published the results of ABSORB III, a clinical trial that compared the safety and effectiveness of Absorb BVS to the XIENCE, metallic drug eluting stent. Learnings from an analysis of the ABSORB III data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. Implementation of these techniques is expected to facilitate optimal clinical outcomes and reduce the possibility of thrombosis. AV will be updating the Instructions for Use (IFU) with this information. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Until the updated IFU is available, users are advised to follow the key changes identified in the customer letter while performing lesion sizing and preparation and also, during scaffold deployment to achieve optimal scaffold apposition to the artery wall. AV is also reinforcing the importance of the IFU instructions (including ensuring the vessel size is > 2.0 and < 3.8 mm) and the key changes in letter to facilitate optimal clinical outcomes and reduce adverse events such as restenosis and thrombosis.
This action has been closed on the 17/09/2018 |
| Contact Information |
02 8879 2800 - Abbott Vascular Australia |