| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00987-1 |
| Product Name/Description |
Absorb Bioresorbable Vascular Scaffold (BVS) System
All Sizes
ARTG Number: 214148 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Vascular is issuing an update to the recall for product correction that was initiated on December 7, 2015 (TGA Ref: RC-2015-RN-01188-1) for all sizes of Absorb Bioresorbable Vascular Scaffold (BVS) system. The purpose is global alignment of Absorb Indication - Increase from 2.0 mm to 2.5 mm in minimum target vessel diameter indicated for implantation of this coronary stent.
Abbott Vascular plans to align the Indications for Absorb across all geographies for reference vessel diameter and as such the Indication Section and Target Vessel Diameter and Ranges Table of the IFU are being updated. Patients who have had Absorb scaffolds successfully implanted are not affected by this action. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott Vascular are issuing revised Instructions for Use (IFU), and are advising users to ensure; When Performing Lesion Sizing and Preparation, the treated lesion length should be less than the nominal scaffolding length, with reference vessel diameters = 2.5 mm and = 3.75 mm (previously = 2.0 mm and = 3.8 mm).
In small vessels (visually assessed reference vessel diameter = 2.75 mm), on-line QCA or intravascular imaging with intravascular ultrasound or optical coherence tomography is strongly recommended to accurately measure and confirm appropriate vessel sizing. If quantitative imaging determines a vessel size < 2.5 mm, do not implant the Absorb BVS / Absorb GT1 BVS.
Under-expansion of the scaffold may result in scaffold movement. Care must be taken to properly size the scaffold to ensure that the scaffold is in full contact with the arterial wall upon deflation of the balloon. All efforts should be made to assure that the scaffold is not under dilated.
This action has been closed out on the 26/09/2018. |
| Contact Information |
02 8879 2800 - Abbott Vascular |