Post-Surgical Complications After Bladder Outlet Reducing Surgery: An Analysis of The FDA Manufacturer and User Facility Device Experience (MAUDE) Database

• Published in: Urology (Ridgewood, N.J.) Vol. 156; pp. 211 - 215
• Main Authors: Weiss, Jason K., Santucci, Nicole M., Sajadi, Kamran P., Chouhan, Jyoti D.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2021
• Subjects: Databases, Factual; Equipment Failure - statistics & numerical data; Humans; Male; Postoperative Complications - etiology; Product Surveillance, Postmarketing; Prostatectomy - adverse effects; Prostatectomy - instrumentation; Prostatic Hyperplasia - complications; Prostatic Hyperplasia - surgery; Severity of Illness Index; United States; United States Food and Drug Administration; Urinary Bladder Neck Obstruction - etiology; Urinary Bladder Neck Obstruction - surgery; United States
• ISSN: 0090-4295; 1527-9995; 1527-9995
• DOI: 10.1016/j.urology.2021.04.030

To examine voluntary reports in the Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, categorize complications and assign device-related causality with transurethral resection of the prostate (TURP), prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT). A review was performed using the terms “Urolift,” “Rezum,” and “transurethral resection of the prostate” between 01/01/2015 and 12/31/2019. Duplicate and incomplete reports were excluded. The Gupta system was used to report complications and device related causality.1 Pearson's Chi-square analysis was performed to compare minor (Level 1) versus major (Levels 2-4) complications. A total of 548 events were examined. After removal of duplicates (n = 60), irrelevant reports (n=65), and incomplete information (n = 14), we included 409 events (74.6%). Of the 409 events, 214 were for TURP, 112 for TWVT, and 83 for PUL. In aggregate, 39.4% of events were minor/Level 1 (n=161/409). The proportion of subjects with Level 2-4 complications versus Level 1 complications was significantly higher for PUL than TURP or TWVT [X2 (2, N = 408) = 41.4023, P < .00001]. Device causality was attributable to device malfunction in 60.4% of cases (n=247/409). Device malfunction was noted in all groups and 39.4% of these were minor (Level 1). However, the majority of PUL reports noted a Level 3 or 4 complication (50.6%, 42/83), primarily bleeding related. Previous studies have not revealed significant risk of bleeding and suggests a discrepancy between study data and real-world experience that may alter patient counseling practices.