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

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.