To better understand the frequency of Pipeline flow diverters’ malfunctioning and the impact of these issues on patient outcomes during the treatment of intracranial aneurysms, we utilized ten years of real-world data from the MAUDE database.

The Manufacturer and User Facility Device Experience (MAUDE) database serves as the U.S. national system for monitoring problems and adverse events related to medical devices after they are released to the market.

All reports related to the "Intracranial Aneurysm Flow Diverter" device class were extracted from the MAUDE database between August 2015 and September 2025. To ensure a comprehensive identification of Pipeline-related adverse events, both device classification and manufacturer-specific queries were employed, targeting the three primary Pipeline manufacturers. Device and patient complications were coded using standardized MAUDE terminology. Descriptive and network analyses were performed to assess the frequency and associations of reported complications.

Of 34,683 reports, device malfunction accounted for 72.3%, injury for 22.6%, and death for 5.1%. The most common device issues were Activation Failure (39.0%), Adverse Event Without Identified Device or Use Problem (14.1%), Physical Resistance/Sticking (11.2%), and Material Deformation (8.4%). Migration appeared in 1.4% (n=762), Positioning Failure in 1.9% (n=1,002). Patient problems were Intracranial Hemorrhage (6.3%), Stenosis (5.1%), Thrombosis/Thrombus (3.7%), Ischemic Stroke (2.9%), Stroke/CVA (2.8%), and Death (2.5%). Severe (Intracranial Hemorrhage, Stroke/CVA, Death) made up 3,665 (14.4%). Network analysis identified Activation Failure, Physical Resistance/Sticking, and Material Deformation as the core device difficulties with the highest frequency and also the most frequent co-occurrence. Positioning Failure, Unintended Movement, and Migration, though less frequent, were consistently linked to these core malfunctions and strongly associated with serious complications, including stroke and death.