Category: BPH/LUTS: Outcomes & Complications

MP11-16 - Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia (BPH) Surgery: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database

Fri, Sep 21
2:00 PM - 4:00 PM

Introduction & Objective :

The development of minimally invasive therapies for benign prostatic hyperplasia (BPH) management to decrease complications and increase efficiency has been an area of interest for both physicians and patients. We sought to investigate contemporary BPH treatment device related adverse events using a standardized classification system to help physicians select a modality that is associated with minimal harm. 


Methods : The MAUDE database was queried from January 2015 to September 2017 using the following terms: “Transurethral resection of prostate (TURP), Holmium Laser Enucleation of the Prostate (HOLEP), Greenlight, and Urolift.” All devices were evaluated for malfunction, patient complications, and manufacturer review. A novel MAUDE classification system was used to standardize complications. Univariable analysis was utilized to identify a relationship between the BPH devices and serious adverse events.


Results : A total of 2558 reports were identified: TURP 188 (7.35%), HOLEP 39 (1.52%), Greenlight 2315 (90.5%) and Urolift 16 (0.63%). The most common deviation included cutting loop detachment during TURP 116 (61.7%), morcellator dysfunction for HOLEP 23 (69.7%), tip fracture/detachment for Greenlight (68.8%), and failure to deploy during Urolift 10 (62.5%). Total complications for all modalities included conversion to open 6 (42.9%), cutaneous burns 3 (21.4%), and urethral injury 2 (14.3%). Approximately 2542 (99.4%) patients experienced no complications (MAUDE I), while 14 (0.6%) patients required medical/surgical management (MAUDE II-IV).  Despite having a higher number of malfunctions reported, Greenlight demonstrated no major harm with an absolute risk reduction of 0.479 and a number needed to treat of 2. No significant relationship was seen between each modality and complications. No deaths were reported. The device was evaluated by the manufacturer in 61.7% of cases, with 41.3% of reviewed cases listing the source of malfunction as misuse by the operator.


Conclusions :

Use of TURP, HOLEP, Greenlight, and Urolift have minimal patient harm with over 99% of patients experiencing no complication when a device malfunction has occurred. Manufacturer review reveals that over 40% of cases are due to misuse by the user. Urologists should select the modalities they are most comfortable with and well trained in to decrease patient harm and prevent device malfunctions. Furthermore, consideration should be given to use of Greenlight for its safety profile in appropriate clinical settings.

Neel Patel

Resident
New York Medical College
Valhalla, New York

Nikil Uppaluri

New York Medical College
Valhalla, New York

Michael Iorga

New York Medical College
Valhalla, New York

Ariel Schulman

Duke University
Durham, North Carolina

Jonathan Bloom

Research Fellow
National Cancer Institute
Bethesda, Maryland

John Phillips

New York Medical College
Valhalla, New York

Sean Fullerton

New York Medical College
Valhalla, New York

Sensuke Konno

New York Medical College
Valhalla, New York

Muhammad Choudhury

New York Medical College
Valhalla, New York

Majid Eshghi

New York Medical College
Valhalla, New York