PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

Abstract

You have accessJournal of UrologyCME1 Apr 2023PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE Daniel Heidenberg, Ethan Nethery, Nathanael Judge, Kevin Wymer, Scott Cheney, and Mitchell Humphreys Daniel HeidenbergDaniel Heidenberg More articles by this author , Ethan NetheryEthan Nethery More articles by this author , Nathanael JudgeNathanael Judge More articles by this author , Kevin WymerKevin Wymer More articles by this author , Scott CheneyScott Cheney More articles by this author , and Mitchell HumphreysMitchell Humphreys More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Benign prostatic hyperplasia (BPH) affects most men over 60 years old. 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. METHODS: The MAUDE database was queried for “Aquablation, Rezum, Loop Resection, Morcellator, Greenlight Laser, Holmium Laser, and Urolift” from 2018 through 2021. A complication classification system (Level 1-4) 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 “product related” and “non-product related.” Chi squared analysis was performed to identify associations between BPH surgery type and complication classification distribution. RESULTS: A total of 873 device related events were identified. The entries by surgical subtype included: rezum 304 (35%), urolift 33 (4%), TURP 134 (15%), HOLEP 40 (4%), Aquablation 294 (34%), Greenlight laser 68 (8%). 553 complications (63%) were Level I (mild/none), 138 (16%) were Level II (medical management), 164 (19%) were Level III (surgical management), and 16 (2%) was Level IV (life threatening). The most common level II-IV complications by BPH surgery type: aquablation - hematuria (50%), rezum - lower urinary tract symptoms (23%), HOLEP – retained adenoma (23%), urolift – acute urinary retention (12%), greenlight laser – urethral necrosis (2%), transurethral resection of prostate – bladder perforation (3%). Using chi squared analysis, aquablation (p<0.017) and Rezum (p<0.012) were associated with the highest risk of Level II-IV complications compared with other device classes. Overall, “product related” malfunctions were not associated with level II-IV complications. CONCLUSIONS: Aquablation and rezum were associated with a higher proportion of level II-IV complications. However, this difference is not accounted for by “product related” malfunctions, which highlights surgeon experience or other unknown factors as potential sources for adverse events with newer products. A limitation of this study is the total complications per surgical subtype are not fully captured. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1061 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Heidenberg More articles by this author Ethan Nethery More articles by this author Nathanael Judge More articles by this author Kevin Wymer More articles by this author Scott Cheney More articles by this author Mitchell Humphreys More articles by this author Expand All Advertisement PDF downloadLoading ...