Post-market safety patterns of hydrogel dural sealants: a comparative manufacturer and user facility device experience analysis.

Abstract

Background: Polyethylene glycol (PEG) hydrogel dural sealants (DuraSeal, Adherus) reinforce dural closure, but case reports describe cerebrospinal fluid (CSF) leak, infection, and swelling-related neurologic injury. We characterized post-market safety in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, comparing structured problem codes with negation-aware narrative review.

Methods: MAUDE reports from January 1, 2015, to June 30, 2024, mentioning either device were extracted and deduplicated by unique identifiers (MDR_REPORT_KEY, REPORT_NUMBER). Structured FDA patient and device problem codes were mapped to clinical categories (CSF leak, infection, wound dehiscence, neurologic deficit, swelling/mass effect, polymerization/application issue, adhesion, reoperation/hospitalization). Narratives underwent deterministic, negation-aware screening for the same categories, and for each device we calculated event proportions.

Results: After deduplication, 279 reports were analyzed (256 DuraSeal, 23 Adherus). Most were coded as injury or malfunction; deaths were rare. CSF leak was the most frequent signal (DuraSeal 26.2% structured vs. 27.0% narrative; Adherus 52.2% vs. 47.8%). For DuraSeal, narrative review nearly doubled infection reports (8.2% vs. 19.9%) and identified swelling/mass effect (9.4%), neurologic deficit (4.3%), and reoperation/hospitalization (7.8%) largely absent from structured codes. For Adherus, narrative review identified isolated reports of infection, swelling/mass effect, and reoperation.

Conclusions: PEG hydrogel dural sealants show post-market safety patterns dominated by CSF leak, suspected infection, and swelling-related neurologic events. Exclusive reliance on structured MAUDE codes underestimates key complications. Integrating structured fields with negation-aware narrative review yields a more complete safety profile and supports cautious use in constrained intracranial spaces.