Medical device manufacturer, Bolton Medical, has issued a field safety notice (FSN) concerning its Relay and Relay NBS Thoracic Stent-Graft Systems with the following information:
According to the FSN, it has been observed in a small number of cases that the Inner Secondary Sheath may not fully exit the Outer Primary Sheath upon reaching the black line. In this situation, the distal end of the stent-graft will also remain within the Outer Primary Sheath. Failure to recognize this condition prior to deployment can lead to deployment difficulty or deployment failure. There is no impact on devices already implanted.
The manufacturer is recommending the following additional verification steps prior to proceeding to the final stent-graft positioning and deployment:
1) Upon reaching the intended proximal landing zone, visually confirm that the distal stent marker bands can be seen approximately 2cm outside of the Outer Primary Sheath.
2) If the distal stent marker bands do not appear to have exited the Outer Primary Sheath, while in Position 1, hold the gray Deployment Grip stationary while pulling back on the black Stationary Grip until the distal stent marker bands have exited the Outer Primary Sheath by approximately 2cm.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 12 Aug 2014