PD51-06\u2003DEVICE-RELATED COMPLICATIONS DURING RENAL CRYOABLATION: LESSONS FROM THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE

Abstract

INTRODUCTION AND OBJECTIVES: Cryoablation is gaining acceptance for the treatment of certain renal masses < 3 cm. While considered minimally invasive, its adverse event profile is still being developed. Using the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, we sought to explore the extent of renal cryoablation device-related complications. METHODS: We collected and analyzed reports on renal cryoablation submitted to the MAUDE database from 2015 to 2018. Cases were examined regarding device malfunction, patient complications and manufacturer assessment. Established MAUDE complication-reporting schemes were used for stratification. Chi square analysis was performed to compare device and non device related complication rates. RESULTS: 80 cases were identified. 73 used Galil needles and 7 used the Endocare system. 10 (12.5%) cases could not be completed. Reported problems were associated with the instrument, operator error, computer system, gas related issue and direct patient complication. There were 15 (18.8%) major complications (MAUDE 3 to 4) and 10 (12.5%) minor complications (MAUDE 2). 3 (3.8%) deaths (MAUDE 4) occurred, but each case seemed primarily related to baseline comorbidity. Using another established stratification, 57 complications were undeniably device related while 23 complications were not definitively device related; on analysis, device related complications were significantly less likely to require at least minor intervention (MAUDE 2 to 4, p=0.00). Of the 60 (75%) cases where the device was evaluated by the manufacturer, the company accepted blame in 30. CONCLUSIONS: Though renal cryoablation is largely well tolerated, there is a diverse set of device-related and procedural complications reported in recent years. Several device, patient, and possibly physician related aspects appear to contribute to these adverse events. These findings are useful to further improve on the procedure and realistically counsel patients on potential morbidity. Table. No title available. Table. No title available. Source of Funding: None