343 - Insights from the FDA MAUDE Database on Device- and Patient-Related Adverse Events in the Use of the AngioDynamics NanoKnife System for Irreversible Electroporation

Purpose: The AngioDynamics NanoKnife System received FDA clearance in 2011 for the irreversible electroporation of soft tissue, with a next-generation system cleared in 2019 and expanded indications, including prostate tissue ablation in late 2024 following the PRESERVE trial {1}. With its increasing adoption and broadened clinical use, this study aimed to conduct a systematic analysis of adverse events reported in the FDA MAUDE database to characterize the device’s safety profile.

Materials and Methods: Adverse event reports linked to the NanoKnife System from February 2015 to August 2025 were extracted from the FDA MAUDE database using the brand name “NanoKnife” {2}. Duplicates were excluded. Reports were categorized into device-related malfunctions and patient-related complications. Frequencies of device problems and patient problems were calculated and analyzed.

Results: A total of 108 reports were included. The most common device malfunctions were failure of device self-test (8.3%), communication or transmission problems (6.5%), arcing of electrodes (5.6%), failure to deliver energy (4.6%), and unexpected shutdown (4.6%). Patient-related complications included arrhythmias (atrial/ventricular fibrillation or tachycardia; 11.1%), fistula formation (9.3%), tissue damage or breakdown (7.4%), hemorrhage/bleeding (6.5%), and thrombosis/thrombus (4.6%). Less frequent events included pain, urinary tract infection, bacterial infection, embolism, obstruction, bradycardia, hypotension, aneurysm, heart failure, cardiac arrest, paresis, movement disorder, and skin discoloration or inflammation. Seven patient deaths (6.5%) were reported, primarily associated with pancreatic and other abdominal organ ablations, often linked to gastrointestinal bleeding or organ failure.

Conclusion: This analysis highlights a range of device malfunctions and patient complications associated with the NanoKnife System as captured in the MAUDE database. The relatively high frequency of fistula formation and cardiac events raises important safety considerations. Ongoing surveillance, operator awareness, and refinements in procedural technique are warranted to optimize the safety and clinical outcomes of irreversible electroporation therapies.