Avvigo+, a next-generation system, provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include percutaneous coronary intervention (PCI) procedures. Boston Scientific picked up FDA clearance for the system in September 2023.

The notice, which came out of Germany, said the anomaly occurs only when the system connects to the OptiCross 18 peripheral imaging catheter and either “Live” or “Record” mode is in use.

Boston Scientific received reports indicating that the grid mark overlay on the cross-sectional view failed to present correctly when Avvigo+ was connected to an OptiCross 18 catheter in either Live or Record mode. The company’s investigation determined that the software anomaly led to this incorrect 9-grid mark overlay display. The company says the correct overlay display for this catheter is the 15-grid mark overlay. However, using “Review” mode, the correct overlay still displays with these technologies.

According to the notice, the most common outcome associated with the anomaly is a procedure delay. This occurs when the physician has to troubleshoot and confirm an accurate measurement. It could lead to an inaccurate assessment of vessel sizing, requiring additional intervention to address stent migration or embolism.

Boston Scientific received no reports of patient complications. The company recommends using measurement tools available in Review mode only to take vessel measurements. A physician can also manually adjust the depth settings or elect to remove grid marks from the display at the time of use. The company has a software update under development to address the anomaly.