Presented by: Mouneeb Choudry MD
Mayo Clinic Arizona

Introduction

Our aim was to evaluate the proportion of clinically significant complications for patients who underwent BPH surgical interventions based on procedure type.  The Manufacturer and User Facility Device Experience (MAUDE) database is an FDA maintained public database that contains anonymous, voluntary medical device reports.  Herein, we review device-related adverse events reported in the MAUDE database associated with BPH surgeries using a standardized classification system.  We then sought to determine the factors contributing to these adverse events.

Materials

The MAUDE database was queried for “Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Rezum, Loop Resection, and Urolift” from 2018 through 2021.  The circumstances and patient complications associated with each surgical technology were identified.  A complication classification system (Level I-IV) based on the Clavien-Dindo system was used to categorize events based on outcomes.  These events were then correlated with device malfunctions and classified as “device related” and “non-device related.”  Chi squared analysis was performed to identify associations between BPH surgery type and complication classification distribution. 

Results

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A total of 873 adverse events were identified.  The adverse events were classified into level I (minimal harm) vs levels II-IV (clinically significant).  Overall, most complications were associated with minimal patient harm.  Aquablation (p<0.017) and Rezum (p<0.012) were associated with the highest relative incidence of Level II-IV complications compared with other procedure types.  Overall, device related malfunctions were not more likely to be associated with level II-IV complications relative to non-device related malfunctions (p = 0.212).

Conclusion

Based on the MAUDE database, among common BPH surgical devices, Aquablation and Rezum were associated with a higher proportion of clinically significant complications.  However, this did not appear to be driven by device-related malfunctions - highlighting other factors as a potential source for adverse events with newer products.

Funding

None

Lead Authors

Daniel Heidenberg, MD
Mayo Clinic Arizona

Co-Authors

Ethan Nethery,
Virginia Tech Carilion School of Medicine and Research Institute

Kevin Wymer, MD
Mayo Clinic Arizona

Nathaneal Judge,
Michigan Technological University

Scott Cheney, MD
Mayo Clinic Arizona

Mitchell Humphreys, MD
Mayo Clinic Arizona