Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database.
INTRODUCTION AND OBJECTIVES: Cryoablation offers a treatment option for small renal masses ideally suited ≤3 cm. In well-selected candidates, it is associated with less perioperative morbidity compared to more invasive options, such as partial or radical nephrectomy. However, little is known regarding device-related complications associated with the procedure. We provide an analysis of reports on renal cryoablation from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Reports on renal cryoablation submitted to the MAUDE database from 2015 through 6/2021 were analyzed. Cases not pertaining to renal cryoablation were excluded (n = 33). Reports were examined to identify patient morbidity related to a potential device malfunction, as well as manufacturer assessment. Complications were graded based on an established MAUDE complication-reporting stratification. Fisher's Exact test was utilized to analyze for associations between device-related adverse events and severity of post-treatment sequelae. RESULTS: Two hundred and thirty-nine unique cases were identified. Adverse events were related to issues with the needles or system (212 cases), technical error (12 cases), or complication related to patient or tumor complexity (14 cases). There were 187 (78.6%) minor complications (MAUDE 1-2) and 52 (21.4%) major complications (MAUDE 3-4). The manufacturer performed formal device review in 164 (68.6%) cases, accepting responsibility for malfunction in 41. Notable MAUDE 3 complications included 29 (12.1%) cases aborted due to instrument/system malfunction and 14 (5.9%) cases of hemorrhage requiring a subsequent procedure. All 3 reported patient deaths (MAUDE 4) appeared to be a consequence of poor baseline health. On statistical analysis, major complications were seen in a significantly higher proportion of non-device related adverse events compared to device related events (85.2% vs. 13.7%, P < .001). CONCLUSION: While renal cryoablation is associated with low overall perioperative morbidity, there is a diverse set of device-related and procedural complications reported in recent years. Device-related adverse events were often associated with minor complications, and major complications were often seen in higher risk patients with comorbidities, more complex tumors, and after technical error. These findings highlight the need for standardized reporting of complications, optimized patient selection and counseling to ensure the best outcomes.
Kotamarti, Srinath, Zoe Michael, David Silver, Ervin Teper, Alireza Aminsharifi, Thomas J. Polascik, and Ariel Schulman. “Device-related complications during renal cryoablation: insights from the Manufacturer and User Facility Device Experience (MAUDE) database.” Urol Oncol 40, no. 5 (May 2022): 199.e9-199.e14. https://doi.org/10.1016/j.urolonc.2022.03.002.