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Location: Marriott Marquis
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PQA 08 - PQA 08 Genitourinary Cancer, Patient Safety, and Nursing/Supportive Care Poster Q&A

3169 - Real-World Medical Device Reports of PEG Hydrogel Spacers: Analysis of the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

Tuesday, October 1, 2024
2:30 PM – 3:45 PM ET
Location: Hall C

Screen: 31

M. R. Folkert1,2, Y. Shin3,4, D. Vannan3, and S. Rojanasarot3; 1Department of Radiation Medicine, Northwell Health Cancer Institute, Lake Success, NY, 2Radiation Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, 3Boston Scientific, Marlborough, MA, 4University of Cincinnati, Cleveland, OH

Purpose/Objective(s): Increasingly, polyethylene glycol (PEG) hydrogel spacers are being utilized to help reduce rectal toxicity in men undergoing radiotherapy for prostate cancer. Previously published analyses of PEG hydrogel spacers using the Manufacturer and User Facility Device Experience (MAUDE) passive surveillance database have not taken into account the real-world volume of spacers placed as part of standard of care following approval. To contextualize the MAUDE reports for the spacers, we assessed the device-related issues and patient event rates from the database, factoring in a conservative estimate of total spacer units used in the US. Materials/

Methods: The MAUDE database was queried for all medical device reports related to PEG hydrogel spacers using trade and generic names from January 2019 to September 2023 (the “Study Period”). Frequencies of reported device problems or patient events were calculated. We used a conservative estimate of total units sold in the US retrieved from the manufacturer to serve as a proxy for the number of patients receiving the spacers; sales numbers do not directly represent the actual number of patients undergoing spacer procedures. The rates of device issues and patient events were then determined by dividing total reports by total spacer units sold.
Results: A total of 1,088 reports were analyzed for PEG hydrogel spacers compared with an estimated 200,000 units sold, resulting in an overall report rate per unit sold of 0.54%, ranging from 0.27% to 0.64% during the Study Period. The most frequently reported device issues were placement/positioning problem (778 reports; 0.39% of total units sold) and ‘adverse event without identified device or use problem’ (233 reports; 0.12% of total units sold). The most frequently reported AEs indicated ‘no clinical signs, symptoms, or conditions’ (436 reports; 0.22% of total units sold) and ‘pain/discomfort’ (300 reports; 0.15% of total units sold). Approximately 60% of the total device issues with placement/positioning problems had ‘no clinical signs, symptoms, or conditions’ and ‘no consequences or impact to patient’ (462 reports; 0.23% of total units sold).
Conclusion: This analysis shows that with respect to estimated device usage, overall device-related problems and event rates for PEG hydrogel spacers consistently remained below 1%, with a majority having little or no reported clinical consequence. Although still a valuable source of information, given the known limitations of MAUDE, additional real-world evidence may help support making informed decisions involving the incorporation of this technology into prostate cancer treatment to potentially mitigate rectal toxicity in men undergoing radiotherapy for prostate cancer.