"Instructions on how to verify [that] the bend relief is fully engaged with the sealed outflow graft at the time of implant and [a] new caution statement regarding the bend relief connection are included" in the revised labeling, according to a statement issued by the company.
Several problems could arise if the bend relief detaches from the device and the tubing kinks or deforms, including:
- A reduction of blood flow from the device
- Graft thrombosis
- Perforation of the outflow graft